Allopurinol

Product NDC
68788-9831
11-digit product format
687889831
Labeler code
68788
Product ID
68788-9831_6786266a-d0b9-4c72-b072-f840f3790773
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
NDA018877
Marketing category
NDA
Marketing start
2012-06-04
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9831DDiscontinued by firm2026-08-17
excluded packagepackage68788-983168788-9831-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-983168788-9831-3DDiscontinued by firm2026-08-17

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 · 39 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9831-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9831-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9831-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9831-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9831-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9831-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9831-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9831-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9831-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9831-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9831-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9831-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9831-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9831-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9831-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9831-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9831-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9831-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9831-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9831-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9831-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9831-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9831-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9831-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68788-9831-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68788-9831-3IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
N018877-001ALLOPURINOLALLOPURINOL300MGTABLET / 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
N018877-001AB

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 06:07:402026-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018877-001ALLOPURINOL300MGTABLET / 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 06:07:402026-07N018877-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018877-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018877-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018877-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018877-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018877-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018877-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018877-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018877-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018877-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018877-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018877-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018877-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018877-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018877-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018877-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018877-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018877-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018877-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018877-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018877-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018877-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018877-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018877-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018877-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018877-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018877-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018877-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018877-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018877-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018877-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018877-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018877-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018877-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018877-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018877-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018877-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018877-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018877-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018877-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLBryant Ranch Prepack7003e410-b4ff-da07-5571-07e7e13f67e02024-05-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877
AllopurinolALLOPURINOLActavis Pharma, Inc.a80fe56f-8d03-423f-8e2a-7ec8c9e5045b2024-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877
AllopurinolALLOPURINOLProficient Rx LP0ca4baed-c5d8-4de4-ac17-6e5d1df15c032023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC9b0e3f11-c02a-443d-806f-134c907ea3712022-12-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877