Allopurinol

Product NDC: 67544-371
11-digit product format: 675440371
Labeler code: 67544
Product ID: 67544-371_64ebbee6-7e2a-455f-9f96-92bc25d3e691
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: ANDA075798
Marketing category: ANDA
Marketing start: 2003-06-27
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: E
Listing certified through: 2017-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-371		I	Inactivated by FDA	2026-08-17
excluded package	package	67544-371	67544-371-30	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-371	67544-371-60	I	Inactivated by FDA	2026-08-17

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-371-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-371-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-371-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-371-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-371-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-371-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-371-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-371-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-371-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-371-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-371-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-371-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-371-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-371-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-371-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-371-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-371-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-371-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-371-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-371-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-371-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-371-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-371-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-371-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67544-371-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67544-371-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67544-371-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67544-371-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67544-371-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67544-371-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67544-371-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67544-371-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67544-371-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67544-371-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67544-371-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67544-371-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67544-371-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67544-371-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67544-371-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67544-371-30	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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
2026-08-18 06:07:40	2026-07	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075798-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075798-002	AB	1	`caaa826d4ba7…`
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ee55bab-4ea8-ac26-c688-380cfbcd5c03	Product name	7	20260127
de89a493-168f-43fa-9852-1f15e00dbb17	Product name	1	20221110
4a2a34d6-1853-423b-9e0c-360370b95802	Product name	1	20171006

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67544-371-30	2019-11-13	C162847	48780-1	97449f38-beca-f6ea-e053-dbdaa90aa703	ALLOPURINOL 100 mg Scored Tablets and 300 mg Scored Tablets
67544-371-60	2019-11-13	C162847	48780-1	97449f38-beca-f6ea-e053-dbdaa90aa703	ALLOPURINOL 100 mg Scored Tablets and 300 mg Scored Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67544-371-30	Allopurinol	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
67544-371-60	Allopurinol	90 in 1 BOTTLE, PLASTIC	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-371-30	EA - Each	67544-371	1f8c9435-dffe-45aa-a119-2ec350b2e956	1	2012-07-24
67544-371-60	EA - Each	67544-371	c9be6c4c-34fb-4daf-816a-0b698c188c14	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-371	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2	Legacy NDC, 2 package rows	20120327_548f6fbb-155f-45ff-ab44-0a70adad4424.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197319	allopurinol 100 MG Oral Tablet	PSN	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197320	allopurinol 300 MG Oral Tablet	PSN	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197319	allopurinol 100 MG Oral Tablet	SCD	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197320	allopurinol 300 MG Oral Tablet	SCD	548f6fbb-155f-45ff-ab44-0a70adad4424	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-371-30	67544037130	30 in 1 BOTTLE, PLASTIC	Historical
67544-371-60	67544037160	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALLOPURINOL 100 mg Scored Tablets and 300 mg Scored Tablets	Aphena Pharma Solutions - Tennessee, Inc. \| Vintage Pharmaceuticals-Charlotte \| Vintage Pharmaceuticals-Huntsville	2012-03-26	HUMAN PRESCRIPTION DRUG LABEL	2