Allopurinol

Product NDC: 50090-0044
Requested package NDC: 50090-0044-3
11-digit product format: 500900044
Labeler code: 50090
Product ID: 50090-0044_eef4126e-685d-422b-b42f-cf7b154d063b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078253
Marketing category: ANDA
Marketing start: 2009-11-16
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0044	50090-0044-3	D	Discontinued by firm		2026-08-10

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078253-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL			2007-09-11
A078253-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL			2007-09-11

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL		2007-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL		2007-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL		2007-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL		2007-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078253-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078253-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078253-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078253-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078253-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078253-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078253-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078253-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078253-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078253-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078253-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078253-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078253-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078253-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078253-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078253-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078253-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078253-002	AB	1	`5aa47cf7b7d7…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-0044-0	2023-02-07	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL TABLETS, for oral use Initial U.S. Approval:1966
50090-0044-1	2023-02-07	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL TABLETS, for oral use Initial U.S. Approval:1966
50090-0044-3	2023-02-07	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL TABLETS, for oral use Initial U.S. Approval:1966
50090-0044-0	2023-01-30	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL TABLETS, for oral use Initial U.S. Approval:1966
50090-0044-1	2023-01-30	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL TABLETS, for oral use Initial U.S. Approval:1966
50090-0044-3	2023-01-30	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL TABLETS, for oral use Initial U.S. Approval:1966

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0044-0	EA - Each	50090-0044	a914ac91-4ffd-4e28-aa59-0ecd10fe8d12	1	2021-05-05
50090-0044-3	EA - Each	50090-0044	c6d91ca6-3703-4be1-a476-cf825dcab9b2	1	2021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63CZ7GJN5I	ALLOPURINOL	315-30-0	ALLOPURINOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0044-3	50090004403	90 TABLET in 1 BOTTLE (50090-0044-3)	90 tablet	2014-11-28	0000-00-00	No	No	Current