Allopurinol

Product NDC: 53217-187
11-digit product format: 532170187
Labeler code: 53217
Product ID: 53217-187_2ca799ba-56af-4fa6-ac9c-44f736ef1a02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
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: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-187		I	Inactivated by FDA	2026-10-20
excluded package	package	53217-187	53217-187-00	I	Inactivated by FDA	2026-10-20
excluded package	package	53217-187	53217-187-30	I	Inactivated by FDA	2026-10-20
excluded package	package	53217-187	53217-187-60	I	Inactivated by FDA	2026-10-20
excluded package	package	53217-187	53217-187-90	I	Inactivated by FDA	2026-10-20

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 · 105 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	53217-187-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-187-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-187-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-187-00	`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	53217-187-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-187-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-187-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-187-00	`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	53217-187-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-187-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-187-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-187-00	`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	53217-187-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-187-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-187-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-187-00	`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	53217-187-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-187-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-187-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-187-00	`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	53217-187-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-187-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-187-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-187-00	`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	53217-187-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-187-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-187-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-187-00	`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	53217-187-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-187-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-187-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-187-00	`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	53217-187-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-187-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-187-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-187-00	`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	53217-187-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-187-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-187-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-187-00	`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	53217-187-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-187-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-187-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-187-00	`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	53217-187-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-187-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-187-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-187-00	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018832-002	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		1984-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018832-002	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 2 · 44 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
2026-10-15 13:18:30	2026-09	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018832-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018832-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018832-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018832-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
53217-187-00	Allopurinol Tablets USP Revised: February 2015 Rx only
53217-187-30	Allopurinol Tablets USP Revised: February 2015 Rx only
53217-187-60	Allopurinol Tablets USP Revised: February 2015 Rx only
53217-187-90	Allopurinol Tablets USP Revised: February 2015 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53217-187-00	Allopurinol	100 in 1 BOTTLE	TABLET	100	1
53217-187-30	Allopurinol	30 in 1 BOTTLE	TABLET	30	1
53217-187-60	Allopurinol	60 in 1 BOTTLE	TABLET	60	1
53217-187-90	Allopurinol	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-187	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20170225_c9a01871-bbf8-4b31-9b9b-9fa8c0997b29.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Actavis Pharma, Inc.	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018832 application number: NDA018832
Allopurinol	ALLOPURINOL	Proficient Rx LP	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018832 application number: NDA018832

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	c9a01871-bbf8-4b31-9b9b-9fa8c0997b29	1
197319	allopurinol 100 MG Oral Tablet	SCD	c9a01871-bbf8-4b31-9b9b-9fa8c0997b29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-187-00	53217018700	100 in 1 BOTTLE	Historical
53217-187-30	53217018730	30 in 1 BOTTLE	Historical
53217-187-60	53217018760	60 in 1 BOTTLE	Historical
53217-187-90	53217018790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol Tablets USP Revised: February 2015 Rx only	Aidarex Pharmaceuticals LLC	2017-02-24	HUMAN PRESCRIPTION DRUG LABEL	1