Allopurinol

Product NDC: 51655-546
11-digit product format: 516550546
Labeler code: 51655
Product ID: 51655-546_4a2a4f63-133c-8b7a-e063-6294a90a0a5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA071586
Marketing category: ANDA
Marketing start: 2023-06-08
Substance: ALLOPURINOL
Active strength: 100 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog.

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	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071586-001	LOPURIN	100MG	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	A071586-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071586-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071586-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071586-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071586-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071586-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071586-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071586-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071586-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071586-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071586-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071586-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071586-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071586-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071586-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071586-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071586-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071586-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071586-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071586-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071586-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071586-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071586-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071586-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071586-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071586-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071586-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071586-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071586-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071586-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071586-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071586-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071586-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071586-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071586-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071586-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071586-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071586-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071586-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071586-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Allopurinol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63CZ7GJN5I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197319	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe06da1b-c493-e238-e053-6294a90a9195	Available on FDA.report

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
51655-546-26	2026-01-29	C162847	48780-1	49896155-a6ee-586f-e063-e6dba90add90	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® (allopurinol) tablets, for oral use Initial U.S. Approval:1966
51655-546-52	2026-01-29	C162847	48780-1	49896155-a6ee-586f-e063-e6dba90add90	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® (allopurinol) tablets, for oral use Initial U.S. Approval:1966

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-546-26	Allopurinol	90 in 1 BOTTLE, PLASTIC	TABLET	90		3
51655-546-52	Allopurinol	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-546	ALLOPURINOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 2 package rows	20240127_fe06da1b-c493-e238-e053-6294a90a9195.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	fe06da1b-c493-e238-e053-6294a90a9195	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586 ndc (product): 51655-546
Allopurinol	ALLOPURINOL	Dr. Reddy's Laboratories Limited	19a138b8-d225-03e6-f762-abe71560204b	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	5a1bfae2-116f-4ef9-bb7b-3b69ac74df03	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	3dc4980c-8062-4239-a860-63888cabee46	2021-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586

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	fe06da1b-c493-e238-e053-6294a90a9195	3
197319	allopurinol 100 MG Oral Tablet	SCD	fe06da1b-c493-e238-e053-6294a90a9195	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-546-26	51655054626	90 TABLET in 1 BOTTLE, PLASTIC (51655-546-26)	90 tablet	2023-10-04	No	No	Current
51655-546-52	51655054652	30 TABLET in 1 BOTTLE, PLASTIC (51655-546-52)	30 tablet	2023-06-08	No	No	Current