ALLOPURINOL

Product NDC
51655-038
11-digit product format
516550038
Labeler code
51655
Product ID
51655-038_5b13daf5-245c-4243-af29-138b79225bb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALLOPURINOL
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA090637
Marketing category
ANDA
Marketing start
2015-02-04
Marketing end
0000-00-00
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct51655-038DDiscontinued by firm2026-08-11
excluded packagepackage51655-03851655-038-52DDiscontinued by firm2026-08-11

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-038-52d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-038-52f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-038-522ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-038-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-038-52cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-038-52cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-038-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-038-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-038-520efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-038-52ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-038-52367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-038-52557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-038-528af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-038-52834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-038-521332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-038-52fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-038-5286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-038-52bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-038-528dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-038-52e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-038-529bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090637-001ALLOPURINOLALLOPURINOL100MGTABLET / ORAL2011-03-16
A090637-002ALLOPURINOLALLOPURINOL300MGTABLET / ORAL2011-03-16

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090637-001ALLOPURINOL100MGTABLET / ORAL2011-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090637-002ALLOPURINOL300MGTABLET / ORAL2011-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090637-001ALLOPURINOL100MGTABLET / ORAL2011-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090637-002ALLOPURINOL300MGTABLET / ORAL2011-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090637-001ALLOPURINOL100MGTABLET / ORAL2011-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090637-002ALLOPURINOL300MGTABLET / ORAL2011-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090637-001ALLOPURINOL100MGTABLET / ORAL2011-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090637-002ALLOPURINOL300MGTABLET / ORAL2011-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090637-001ALLOPURINOL100MGTABLET / ORAL2011-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090637-002ALLOPURINOL300MGTABLET / ORAL2011-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090637-001ALLOPURINOL100MGTABLET / ORAL2011-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090637-002ALLOPURINOL300MGTABLET / ORAL2011-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090637-001ALLOPURINOL100MGTABLET / ORALAB2011-03-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A090637-002ALLOPURINOL300MGTABLET / ORALAB2011-03-16782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090637-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090637-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090637-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090637-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090637-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090637-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090637-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090637-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090637-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090637-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090637-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090637-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090637-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090637-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090637-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090637-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090637-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090637-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090637-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090637-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090637-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090637-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090637-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090637-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090637-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090637-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090637-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090637-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090637-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090637-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090637-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090637-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090637-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090637-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090637-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090637-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090637-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090637-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090637-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090637-002AB1b00525d2431f…

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
51655-038-522026-01-09C16284748780-19d75b9d0-0250-f424-e053-dadaa90a57ceALLOPURINOL
51655-038-522020-01-31C16284748780-19d75b9d0-0250-f424-e053-dadaa90a57ceALLOPURINOL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-038ALLOPURINOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20150324_0ad457ac-d459-4df9-8cba-e14bf794c917.zip