Allopurinol

Product NDC
50090-2544
11-digit product format
500902544
Labeler code
50090
Product ID
50090-2544_f9dc6fdb-1823-4169-a486-9d57687af64a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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 productproduct50090-2544IInactivated by FDA2026-08-17
excluded packagepackage50090-254450090-2544-3IInactivated by FDA2026-08-17
excluded packagepackage50090-254450090-2544-4IInactivated 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 · 45 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 packagepackage50090-2544-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2544-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2544-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2544-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2544-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2544-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2544-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2544-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2544-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2544-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2544-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2544-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2544-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2544-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2544-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2544-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2544-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2544-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2544-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2544-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2544-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2544-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2544-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2544-4557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-2544-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-2544-48af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-2544-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-2544-4834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-2544-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-2544-41332a3947898…d4bfe170f9cd…

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
50090-2544-32023-01-30C16284748780-1f386c649-c22f-0266-e053-dadaa90a7c1aAllopurinol Tablets USP Rx only
50090-2544-42023-01-30C16284748780-1f386c649-c22f-0266-e053-dadaa90a7c1aAllopurinol Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2544-3Allopurinol30 in 1 BOTTLETABLET3010
50090-2544-4Allopurinol90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2544-3EA - Each50090-2544cf815bfa-1da3-4402-baf7-fdffb402674f12019-03-12
50090-2544-4EA - Each50090-25447daa39ba-12e8-411c-92db-e8b8384bf5b112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2544ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20200122_632baede-6ade-450e-afa3-50a6cf1f9c91.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 TabletPSN632baede-6ade-450e-afa3-50a6cf1f9c9110
197320allopurinol 300 MG Oral TabletPSN632baede-6ade-450e-afa3-50a6cf1f9c9110
197319allopurinol 100 MG Oral TabletSCD632baede-6ade-450e-afa3-50a6cf1f9c9110
197320allopurinol 300 MG Oral TabletSCD632baede-6ade-450e-afa3-50a6cf1f9c9110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2544-35009025440330 TABLET in 1 BOTTLE (50090-2544-3) 30 tablet2016-11-300000-00-00NoNoCurrent
50090-2544-45009025440490 TABLET in 1 BOTTLE (50090-2544-4) 90 tablet2016-10-200000-00-00NoNoCurrent