Allopurinol

Product NDC
67296-1265
11-digit product format
672961265
Labeler code
67296
Product ID
67296-1265_d6103513-b2b6-1fd0-e053-2995a90a41ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA018832
Marketing category
NDA
Marketing start
2009-04-06
Marketing end
0000-00-00
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1265IInactivated by FDA2026-08-17
excluded packagepackage67296-126567296-1265-3IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1265-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1265-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1265-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1265-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1265-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1265-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1265-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1265-3IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1265-3IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1265-3IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1265-3IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1265-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1265-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1265-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1265-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1265-3EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018832-002ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB1984-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018832-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018832-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018832-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018832-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018832-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018832-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018832-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018832-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018832-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018832-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018832-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018832-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018832-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018832-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018832-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018832-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018832-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018832-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018832-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018832-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018832-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018832-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018832-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018832-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018832-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018832-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018832-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018832-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018832-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018832-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018832-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018832-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018832-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018832-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018832-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018832-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018832-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018832-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018832-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018832-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018832-002AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ee55bab-4ea8-ac26-c688-380cfbcd5c03Product name720260127
de89a493-168f-43fa-9852-1f15e00dbb17Product name120221110
4a2a34d6-1853-423b-9e0c-360370b95802Product name120171006

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1265-32024-01-30C16284748780-11030e364-f97c-111a-e063-dadaa90a10e24fa7df0b-78ee-4bad-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1265-3Allopurinol30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1265ALLOPURINOL TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220121_4fa7df0b-78ee-4bad-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLActavis Pharma, Inc.a80fe56f-8d03-423f-8e2a-7ec8c9e5045b2024-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018832
application number: NDA018832
AllopurinolALLOPURINOLProficient Rx LP0ca4baed-c5d8-4de4-ac17-6e5d1df15c032023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018832
application number: NDA018832

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN4fa7df0b-78ee-4bad-e054-00144ff8d46c3
197319allopurinol 100 MG Oral TabletSCD4fa7df0b-78ee-4bad-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1265-36729612650330 TABLET in 1 BOTTLE (67296-1265-3) 30 tablet2009-04-060000-00-00NoNoCurrent