Allopurinol

Product NDC: 71610-681
11-digit product format: 716100681
Labeler code: 71610
Product ID: 71610-681_fe21f4f9-59eb-4885-90b5-c2859a714516
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204467
Marketing category: ANDA
Marketing start: 2022-03-01
Substance: ALLOPURINOL
Active strength: 300 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204467-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28
A204467-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28
A204467-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204467-001	AB
A204467-002	AB
A204467-003	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 · 86 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	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A204467-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204467-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204467-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204467-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204467-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204467-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204467-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204467-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204467-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204467-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204467-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204467-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204467-001	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Allopurinol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	300 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
197320	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
a5c35283-09d2-4bb4-bdd1-055035fa272b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-681-45	Allopurinol	45 in 1 BOTTLE	TABLET	45		1
71610-681-60	Allopurinol	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-681-45	EA - Each	71610-681	aebfcfea-4c39-43ce-ab43-c24d0914fe02	1	2024-04-05
71610-681-60	EA - Each	71610-681	4e175754-3fc4-4037-bdd6-0509fdb3da20	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-681	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20221217_a5c35283-09d2-4bb4-bdd1-055035fa272b.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	55280a8a-cf23-405b-b698-95a4d8e3c699	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	6341a72d-9c83-448c-871b-e800ad8f1547	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	b943dbb1-7f54-434c-9439-8ce768d94ff4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	0f8b97d0-4d0b-9f4a-e063-6294a90a033f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	fc37bc7e-b6bc-4aa9-a6f3-6e11285c4f05	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	30529a62-f95a-40e0-b4c5-2cfc09232068	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	ST. MARY'S MEDICAL PARK PHARMACY	4f5c4fbc-3d31-5068-e063-6294a90ab315	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
ALLOPURINOL	ALLOPURINOL	Direct_Rx	f3bd5852-8e43-6b5d-e053-2995a90a194f	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	6d2f2f76-0f2b-45c4-affe-77bd927df589	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Coupler LLC	4a00a35a-cc85-0088-e063-6394a90a0744	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Florida Pharmaceutical Products, LLC	815af471-5985-4819-936d-1f5f3d871ef8	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	52ce5aab-76cf-465d-8f14-c745d382cd15	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	df754efc-4b73-a0ab-e053-2a95a90a6133	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ad6950d4-2cdd-44ac-9b8a-120716460e70	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	165f2ebb-a099-4d31-b21a-93b341c39429	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Indoco Remedies Limited	48a9a6c3-4604-421e-a323-1133888aaf76	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	3845c310-099b-8e11-e063-6394a90abd2f	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Redpharm Drug	0a22fa72-c363-4e96-e063-6394a90a48aa	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	7f9ad8db-ae68-4a0c-b858-1e727bc98130	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	74dba96f-d388-40fe-8bca-53086d28c954	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467

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	a5c35283-09d2-4bb4-bdd1-055035fa272b	1
197320	allopurinol 300 MG Oral Tablet	SCD	a5c35283-09d2-4bb4-bdd1-055035fa272b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-681-45	71610068145	45 TABLET in 1 BOTTLE (71610-681-45)	45 tablet	2022-12-13	0000-00-00	No	No	Current
71610-681-60	71610068160	90 TABLET in 1 BOTTLE (71610-681-60)	90 tablet	2022-12-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALLOPURINOL TABLETS USP 100 mg and 300 mg Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2022-12-13	Human Prescription Drug Label	1