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LABELS · ead13f84-4320-7125-e053-2995a90a9bd2

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
2022-10-12
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 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. Nervous System Acute exacerbations of multiple sclerosis 13. 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
  1. NDA008697
boxed warning exact
    brand names
    1. Hydrocortisone
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=459a9907-1261-4a75-8388-f0e2f466939c
    generic names
    1. HYDROCORTISONE
    id
    ead13f84-4320-7125-e053-2995a90a9bd2
    indications and usage exact
    1. 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. Nervous System Acute exacerbations of multiple sclerosis 13. 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
        manufacturer names
        1. Asclemed USA, Inc.
        matched search terms
        1. cancer
        2. lymphomas
        3. leukemia
        package ndcs
        1. 76420-028-50
        2. 76420-028-90
        product ndcs
        1. 76420-028
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
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          meta
          disclaimer
          Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
          last updated
          2026-09-09
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          source url
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          spl effective date
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          spl effective time
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          substance names
          1. HYDROCORTISONE
          uniis
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          Drugs@FDA application source records
          1. application number
            NDA008697
            payload
            all indexed label documents
            1. Appl No
              008697
              Application Docs Date
              2015-04-15 00:00:00
              Application Docs ID
              32967
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              21
              Submission Type
              SUPPL
            2. Appl No
              008697
              Application Docs Date
              2016-09-09 00:00:00
              Application Docs ID
              45257
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              32
              Submission Type
              SUPPL
            3. Appl No
              008697
              Application Docs Date
              2016-09-09 00:00:00
              Application Docs ID
              45258
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              33
              Submission Type
              SUPPL
            4. Appl No
              008697
              Application Docs Date
              2019-11-22 00:00:00
              Application Docs ID
              61015
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              36
              Submission Type
              SUPPL
            5. Appl No
              008697
              Application Docs Date
              2023-12-21 00:00:00
              Application Docs ID
              77102
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              38
              Submission Type
              SUPPL
            6. Appl No
              008697
              Application Docs Date
              2024-06-06 00:00:00
              Application Docs ID
              78670
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              40
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              40
              Submission Status
              AP
              Submission Status Date
              2024-06-05 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              38
              Submission Status
              AP
              Submission Status Date
              2023-12-20 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              36
              Submission Status
              AP
              Submission Status Date
              2019-11-21 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              33
              Submission Status
              AP
              Submission Status Date
              2016-09-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              32
              Submission Status
              AP
              Submission Status Date
              2016-09-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              25
              Submission Status
              AP
              Submission Status Date
              2001-03-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              21
              Submission Status
              AP
              Submission Status Date
              1993-12-28 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              20
              Submission Status
              AP
              Submission Status Date
              1993-12-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              16
              Submission Status
              AP
              Submission Status Date
              1983-03-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              008697
              Review Priority
              Submission Class Code ID
              3
              Submission No
              14
              Submission Status
              AP
              Submission Status Date
              1978-02-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              008697
              Review Priority
              STANDARD
              Submission Class Code ID
              15
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1952-12-15 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            application number
            NDA008697
            approval interpretation
            Application linkage and approved submission are not indication-level current approval verification
            current indication status
            not_reconciled
            has approved submission record
            true
            latest approved submission date
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            latest label selection rule
            max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
            latest posted label documents
            1. Appl No
              008697
              Application Docs Date
              2024-06-06 00:00:00
              Application Docs ID
              78670
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              40
              Submission Type
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            official application record
            Appl No
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            Appl Public Notes
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            Sponsor Name
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            openfda application present
            true
            products
            1. Active Ingredient
              HYDROCORTISONE
              Appl No
              008697
              Drug Name
              CORTEF
              Form
              TABLET;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
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              Strength
              10MG
              marketing status
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            2. Active Ingredient
              HYDROCORTISONE
              Appl No
              008697
              Drug Name
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              Form
              TABLET;ORAL
              Product No
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              Reference Drug
              1
              Reference Standard
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              marketing status
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            3. Active Ingredient
              HYDROCORTISONE
              Appl No
              008697
              Drug Name
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              Form
              TABLET;ORAL
              Product No
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              Reference Drug
              1
              Reference Standard
              0
              Strength
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              marketing status
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          Source passages and status connections

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          Passage 1 · positive indication candidate
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          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
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                INDICATIONS AND USAGE Hydrocortisone tablets are indicated in the following conditions. 1.
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                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
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                            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.
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