Allopurinol

Product NDC: 50268-064
Requested package NDC: 50268-064-15
11-digit product format: 502680064
Labeler code: 50268
Product ID: 50268-064_d5cbb80c-c31a-ac08-e053-2995a90a264d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA075798
Marketing category: ANDA
Marketing start: 2016-08-01
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50268-064	50268-064-15	D	Discontinued by firm		2026-08-03

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 · 12 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075798-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2003-06-27
A075798-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		2003-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075798-001	AB
A075798-002	AB

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	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075798-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075798-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075798-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075798-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075798-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075798-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075798-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075798-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075798-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075798-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075798-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075798-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075798-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075798-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075798-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-064-11	EA - Each	50268-064	64745ad4-380b-4dcf-a83e-c36c82a4a89b	1	2016-09-02
50268-064-15	EA - Each	50268-064	641e3847-f315-4e46-bbbd-10718a227930	1	2016-09-02

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	b6c5b5c0-b1cb-44c0-a849-5d317e6fa300	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	8c0f5af5-a453-4641-933f-ccb2625fca39	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	NCS HealthCare of KY, LLC dba Vangard Labs	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	4dbced9a-ef6f-455e-8d5d-b635409521db	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	73a374a6-ea1a-40a1-b6eb-d42654df0895	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	f91c2183-e41d-45bc-87aa-edfca5eebac5	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	005048dd-844f-468c-bf56-1a09727e3477	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	90912dd4-5abf-4fd3-8fc1-3afd057b743f	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	e84cd8df-79d8-449f-ace2-5a4de1cdaf51	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Par Health USA, LLC	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798

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
50268-064-15	50268006415	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-064-15) > 1 TABLET in 1 BLISTER PACK (50268-064-11)	50 blister pack	2016-08-01	0000-00-00	No	No	Current