LABELS · dc8eb4a8-0fb0-4964-9d48-b299f99744f6

Allopurinol

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: 2023-02-01
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ). Allopurinol is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.

Full extracted label fields

application numbers

NDA018877
NDA018832

boxed warning exact

brand names

Allopurinol

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

generic names

ALLOPURINOL

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

indications and usage exact

INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ). Allopurinol is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.

indications and usage tables exact

is original packager

manufacturer names

Proficient Rx LP

matched search terms

cancer
lymphoma
leukemia

package ndcs

63187-463-30
63187-463-60
63187-463-90
63187-240-30
63187-240-60
63187-240-90

product ndcs

63187-240
63187-463

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

197319
197320

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.json

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

license

https://open.fda.gov/license/

results

limit: 100
skip: 700
total: 830

terms

https://open.fda.gov/terms/

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl effective time

20230201

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

spl version

substance names

ALLOPURINOL

uniis

63CZ7GJN5I

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
not_identified_as_original_packager
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA018832
payload
all indexed label documents
Appl No
018832
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78051
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
56
Submission Type
SUPPL
Appl No
018832
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78052
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
58
Submission Type
SUPPL
Appl No
018832
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78053
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
61
Submission Type
SUPPL
all submission records
Appl No
018832
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
61
Submission Status
AP
Submission Status Date
2024-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
58
Submission Status
AP
Submission Status Date
2024-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
56
Submission Status
AP
Submission Status Date
2024-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
55
Submission Status
AP
Submission Status Date
2014-09-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
48
Submission Status
AP
Submission Status Date
2014-09-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
3
Submission No
38
Submission Status
AP
Submission Status Date
2009-01-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
27
Submission Status
AP
Submission Status Date
2002-08-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
26
Submission Status
AP
Submission Status Date
2001-04-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
25
Submission Status
AP
Submission Status Date
2001-02-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
3
Submission No
24
Submission Status
AP
Submission Status Date
2003-08-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
22
Submission Status
AP
Submission Status Date
1998-03-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018832
Review Priority
Submission Class Code ID
4
Submission No
21
Submission Status
AP
Submission Status Date
1998-03-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA018832
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018832
has approved submission record
true
latest approved submission date
2024-04-03
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
Appl No
018832
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78051
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
56
Submission Type
SUPPL
Appl No
018832
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78052
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
58
Submission Type
SUPPL
Appl No
018832
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78053
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
61
Submission Type
SUPPL
official application record
Appl No
018832
Appl Public Notes
Appl Type
NDA
Sponsor Name
WATSON LABS
openfda application present
true
products
Active Ingredient
ALLOPURINOL
Appl No
018832
Drug Name
ALLOPURINOL
Form
TABLET;ORAL
Product No
002
Reference Drug
0
Reference Standard
0
Strength
100MG
marketing status
Prescription
application number
NDA018877
payload
all indexed label documents
Appl No
018877
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78054
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
63
Submission Type
SUPPL
Appl No
018877
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78055
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
65
Submission Type
SUPPL
Appl No
018877
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78056
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
68
Submission Type
SUPPL
all submission records
Appl No
018877
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
68
Submission Status
AP
Submission Status Date
2024-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
65
Submission Status
AP
Submission Status Date
2024-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
63
Submission Status
AP
Submission Status Date
2024-04-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
62
Submission Status
AP
Submission Status Date
2015-11-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
3
Submission No
45
Submission Status
AP
Submission Status Date
2009-01-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
31
Submission Status
AP
Submission Status Date
2002-08-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
30
Submission Status
AP
Submission Status Date
2001-04-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
29
Submission Status
AP
Submission Status Date
2001-02-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
3
Submission No
28
Submission Status
AP
Submission Status Date
2003-08-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
26
Submission Status
AP
Submission Status Date
1998-03-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
25
Submission Status
AP
Submission Status Date
1998-03-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
018877
Review Priority
Submission Class Code ID
4
Submission No
21
Submission Status
AP
Submission Status Date
1993-07-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA018877
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018877
has approved submission record
true
latest approved submission date
2024-04-03
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
Appl No
018877
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78054
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
63
Submission Type
SUPPL
Appl No
018877
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78055
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
65
Submission Type
SUPPL
Appl No
018877
Application Docs Date
2024-04-03 00:00:00
Application Docs ID
78056
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018832s056s058s061,018877s063s065s068lbl.pdf
Submission No
68
Submission Type
SUPPL
official application record
Appl No
018877
Appl Public Notes
Appl Type
NDA
Sponsor Name
WATSON LABS
openfda application present
true
products
Active Ingredient
ALLOPURINOL
Appl No
018877
Drug Name
ALLOPURINOL
Form
TABLET;ORAL
Product No
001
Reference Drug
0
Reference Standard
0
Strength
300MG
marketing status
Prescription

Source passages and status connections

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

Passage 1 · unclassified context

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 252
end exclusive: true
exact text: INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires a
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 0

current approval status

not_reconciled

duplicate text group

dup-e6b974a17c6cc79b4eda

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-0e8c0de4fb415be8ce2e

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 52
end exclusive: true
exact text: INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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 2 · limitation of use

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 323
end exclusive: true
exact text: INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICA
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 0

current approval status

not_reconciled

duplicate text group

dup-1f2a4386c0ab0bef1730

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-114de8644120654cd827

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 123
end exclusive: true
exact text: IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 53

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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

not_applicable

Passage 3 · unclassified context

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 387
end exclusive: true
exact text: INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ).
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 0

current approval status

not_reconciled

duplicate text group

dup-b94baf986d7b5b9dc89d

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-8609fd1a0757f2ed58d9

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 187
end exclusive: true
exact text: Allopurinol reduces serum and urinary uric acid concentrations.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 124

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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 · risk or warning

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 587
end exclusive: true
exact text: INDICATIONS AND USAGE THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ). Allopurinol is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the ma
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 0

current approval status

not_reconciled

duplicate text group

dup-94f2f5a151d055b4d4ae

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-4ffc10ea4b9bc2ae9849

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 387
end exclusive: true
exact text: Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ).
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 188

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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

not_applicable

Passage 5 · positive indication candidate

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 944
end exclusive: true
exact text: Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ). Allopurinol is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uri
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 188

current approval status

not_reconciled

duplicate text group

dup-ea66015c086ab717a39c

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-b55d0e8f297c6d60a087

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

end: 412
end exclusive: true
exact text: is indicated
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 400

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 744
end exclusive: true
exact text: Allopurinol is indicated in: the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 388

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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

tumor_directed_candidate

Passage 6 · positive indication candidate

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1220
end exclusive: true
exact text: cid lithiasis, and/or nephropathy). the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 545

current approval status

not_reconciled

duplicate text group

dup-6e89e9016e5e7333678c

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-6f0344e3976948d04a56

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

end: 412
end exclusive: true
exact text: is indicated
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 400

qualifier mentions

context exact
acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients an
kind
stage_or_setting
polarity
not_inferred
span
end
939
end exclusive
true
exact text
recurrent calcium oxalate calculi whose dail
label id
dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start
895

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 1031
end exclusive: true
exact text: Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 745

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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 7 · unclassified context

application numbers

NDA018877
NDA018832

brand names

Allopurinol

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1220
end exclusive: true
exact text: ric acid is no longer present. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 832

current approval status

not_reconciled

duplicate text group

dup-8ea2a88997a88458a160

extraction review status

automated_candidate_pending_source_review

generic names

ALLOPURINOL

ind-span-2537c4ed057b8e4e9520

label id

dc8eb4a8-0fb0-4964-9d48-b299f99744f6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 1220
end exclusive: true
exact text: Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
label id: dc8eb4a8-0fb0-4964-9d48-b299f99744f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 0332461f494facec84606472c3269744adfb6630a76098a92f440d5d66a26629
start: 1032

source url

https://api.fda.gov/drug/label.json?search=id%3A%22dc8eb4a8-0fb0-4964-9d48-b299f99744f6%22

spl effective date

2023-02-01

spl set id

0ca4baed-c5d8-4de4-ac17-6e5d1df15c03

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