Allopurinol

Product NDC: 43353-088
11-digit product format: 433530088
Labeler code: 43353
Product ID: 43353-088_6afb5447-b318-40d5-8ec7-43ae3318f3bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA071587
Marketing category: ANDA
Marketing start: 2015-02-09
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-088		I	Inactivated by FDA		2026-08-07
excluded package	package	43353-088	43353-088-60	I	Inactivated by FDA		2026-08-07

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 · 30 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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`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	43353-088-60	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071587-001	LOPURIN	ALLOPURINOL	300MG	TABLET / ORAL	AB		1987-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071587-001	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 2 · 41 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	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071587-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071587-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071587-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071587-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071587-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071587-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071587-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071587-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071587-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071587-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071587-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071587-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071587-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071587-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071587-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071587-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071587-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071587-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071587-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071587-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071587-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071587-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071587-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071587-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071587-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071587-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071587-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071587-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071587-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071587-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071587-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071587-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071587-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071587-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071587-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071587-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071587-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071587-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071587-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071587-001	AB	1	`cb3db0bc1861…`

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
43353-088-60	2023-01-30	C162847	48780-1	f386c649-dcf4-0266-e053-dadaa90a7c1a	Allopurinol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-088-60	Allopurinol	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-088-60	EA - Each	43353-088	ef5ce6b3-c7e8-4476-9317-4811b6cb5d29	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-088	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 1 package rows	20191219_eeb51b29-5b46-495d-9c86-8afd710404bc.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	da814597-50e6-48fa-e053-2995a90ab21b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071587 application number: ANDA071587
Allopurinol	ALLOPURINOL	Dr. Reddy's Laboratories Limited	19a138b8-d225-03e6-f762-abe71560204b	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071587 application number: ANDA071587
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	278df77c-3a9c-4c7d-ba8f-eb33f6335ef4	2022-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071587 application number: ANDA071587

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
197320	allopurinol 300 MG Oral Tablet	PSN	eeb51b29-5b46-495d-9c86-8afd710404bc	3
197320	allopurinol 300 MG Oral Tablet	SCD	eeb51b29-5b46-495d-9c86-8afd710404bc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-088-60	43353008860	90 TABLET in 1 BOTTLE (43353-088-60)	90 tablet	2015-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol Tablets	Aphena Pharma Solutions - Tennessee, LLC	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	3