LABELS · ac03d89e-21e7-4bd4-8355-cafa20808953

Hydrocortisone

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-05-25
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

Full extracted label fields

application numbers

NDA008697

boxed warning exact

brand names

Hydrocortisone

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc751403-94f2-4f9d-b533-cf6186a40ceb

generic names

HYDROCORTISONE

ac03d89e-21e7-4bd4-8355-cafa20808953

indications and usage exact

INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

indications and usage tables exact

is original packager

true

manufacturer names

Mylan Pharmaceuticals Inc.

matched search terms

cancer
lymphomas
leukemia

package ndcs

59762-0073-1
59762-0074-1
59762-0075-1

product ndcs

59762-0073
59762-0074
59762-0075

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

197782
197783
197787

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 290
end exclusive: true
exact text: INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where appl
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 0

current approval status

not_reconciled

duplicate text group

dup-9e3385487162843a99fb

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-db582e6e44724f295676

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

end: 58
end exclusive: true
exact text: are indicated
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 45

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 90
end exclusive: true
exact text: INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 1.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 2 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 670
end exclusive: true
exact text: INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rh
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 0

current approval status

not_reconciled

duplicate text group

dup-a8c38b6885453d07873f

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-8d212581fe65bfb73363

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 470
end exclusive: true
exact text: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 91

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1126
end exclusive: true
exact text: rticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 271

current approval status

not_reconciled

duplicate text group

dup-cfcd7ae27532368cac22

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-feb2d72e24d4eb70055c

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 926
end exclusive: true
exact text: Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 471

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1312
end exclusive: true
exact text: aintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic derm
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 727

current approval status

not_reconciled

duplicate text group

dup-986ced910f4ae2130a0e

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-51aa0e6591871635712e

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1112
end exclusive: true
exact text: Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 927

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1521
end exclusive: true
exact text: condylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asth
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 913

current approval status

not_reconciled

duplicate text group

dup-3498290689533db97e73

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-ff3cc106520632481d49

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1321
end exclusive: true
exact text: Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1113

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 6 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1795
end exclusive: true
exact text: gic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zo
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1122

current approval status

not_reconciled

duplicate text group

dup-1831ad4791e1f161a5ab

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-762e55565e10330f9ec6

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1595
end exclusive: true
exact text: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1322

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2166
end exclusive: true
exact text: tractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate a
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1396

current approval status

not_reconciled

duplicate text group

dup-3a2920e4ed930f0e00ab

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-91fd51cbe26de050b316

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1966
end exclusive: true
exact text: Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1596

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 8 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2419
end exclusive: true
exact text: al marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid)
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1767

current approval status

not_reconciled

duplicate text group

dup-222da383165843fe2ff1

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-350df51b91929a06a8a0

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2219
end exclusive: true
exact text: Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 1967

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 9 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2640
end exclusive: true
exact text: 's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2020

current approval status

not_reconciled

duplicate text group

dup-fe7ca92832d15fe393a9

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-65940d7fdf991c4209ee

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

context exact
ematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune)
kind
age
polarity
not_inferred
span
end
2287
end exclusive
true
exact text
adults
label id
ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start
2281
context exact
bocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (
kind
age
polarity
not_inferred
span
end
2324
end exclusive
true
exact text
adults
label id
ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start
2318

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2440
end exclusive: true
exact text: Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2220

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 10 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2756
end exclusive: true
exact text: Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases T
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2241

current approval status

not_reconciled

duplicate text group

dup-439a0c397dc00de12db7

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-c7bd70ed20698463509a

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

context exact
es For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.
kind
age
polarity
not_inferred
span
end
2524
end exclusive
true
exact text
adults
label id
ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start
2518

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2556
end exclusive: true
exact text: Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2441

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 11 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2928
end exclusive: true
exact text: anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impen
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2357

current approval status

not_reconciled

duplicate text group

dup-91f352d1ee68406609e8

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-cb74ea2e750dbd2ea52e

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2728
end exclusive: true
exact text: Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2557

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 12 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 3058
end exclusive: true
exact text: e leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvem
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2529

current approval status

not_reconciled

duplicate text group

dup-3f5acc798dc519cf7584

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-b7bfe0051ec0413ca4e4

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 2858
end exclusive: true
exact text: Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2729

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 13 · unclassified context

application numbers

NDA008697

brand names

Hydrocortisone

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 3061
end exclusive: true
exact text: remia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2659

current approval status

not_reconciled

duplicate text group

dup-7a204fb86c6502b4e438

extraction review status

automated_candidate_pending_source_review

generic names

HYDROCORTISONE

ind-span-71184b977bfbfc6de372

label id

ac03d89e-21e7-4bd4-8355-cafa20808953

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 3061
end exclusive: true
exact text: Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
label id: ac03d89e-21e7-4bd4-8355-cafa20808953
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0da421369f5cf860e42cc6fcff3957d04c383452b138bb97168a6edfcdacc515
start: 2859

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ac03d89e-21e7-4bd4-8355-cafa20808953%22

spl effective date

2026-05-25

spl set id

bc751403-94f2-4f9d-b533-cf6186a40ceb

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice