LABELS · cf8169e9-905c-44b3-8a4f-14c4f3edfc75

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: 2024-05-22
Captured: 2026-09-09T23:37:58.719708+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. Treatment with allopurinol 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

boxed warning exact

brand names

Allopurinol

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7003e410-b4ff-da07-5571-07e7e13f67e0

generic names

ALLOPURINOL

cf8169e9-905c-44b3-8a4f-14c4f3edfc75

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. Treatment with allopurinol 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

Bryant Ranch Prepack

matched search terms

cancer
lymphoma
leukemia

package ndcs

63629-1781-4
63629-1781-1
63629-1781-2
63629-1781-3
63629-1781-5

product ndcs

63629-1781

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

197320

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.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: 600
total: 830

terms

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

sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

url

source url

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spl effective date

2024-05-22

spl effective time

20240522

spl set id

7003e410-b4ff-da07-5571-07e7e13f67e0

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

Drugs@FDA application source records

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

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brand names

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generic names

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source url

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spl effective date

2024-05-22

spl set id

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spl version

structured fields status

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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

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brand names

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classification reasons

negative_or_not_established_clause

clinical review status

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content role

limitation_of_use

context span

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source url

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spl effective date

2024-05-22

spl set id

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structured indication

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line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Passage 3 · unclassified context

application numbers

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brand names

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classification reasons

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clinical review status

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content role

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context span

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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
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qualifier mentions

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source url

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spl effective date

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spl set id

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structured fields status

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structured indication

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tumor histology: Source null

use intent

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Passage 4 · risk or warning

application numbers

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brand names

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classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

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risk_or_warning

context span

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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
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Passage 5 · positive indication candidate

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exact text: s 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. Treatment with allopurinol 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 dail
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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.
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source url

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spl effective date

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structured indication

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

use intent

tumor_directed_candidate

Passage 6 · positive indication candidate

application numbers

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