Allopurinol

Product NDC: 0904-6572
11-digit product format: 009046572
Labeler code: 0904
Product ID: 0904-6572_e8995c18-7672-418d-8e39-bffe2ad7c7fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075798
Marketing category: ANDA
Marketing start: 2003-06-27
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 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…`

Additional Listing Data#

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

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
8c0f5af5-a453-4641-933f-ccb2625fca39	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
0904-6572-61	Allopurinol	100 in 1 CARTON	TABLET	100		11
0904-6572-61	Allopurinol	1 in 1 BLISTER PACK	TABLET	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6572-61	EA - Each	0904-6572	32b17cf2-6359-4c1f-9985-610c7a93fa63	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6572	ALLOPURINOL TABLET [MAJOR PHARMACEUTICALS]	10	Current NDC, Legacy NDC, 2 package rows	20250210_8c0f5af5-a453-4641-933f-ccb2625fca39.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 ndc (product): 0904-6572
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
197320	allopurinol 300 MG Oral Tablet	PSN	8c0f5af5-a453-4641-933f-ccb2625fca39	11
197320	allopurinol 300 MG Oral Tablet	SCD	8c0f5af5-a453-4641-933f-ccb2625fca39	11
197320	allopurinol 300 MG Oral Tablet	PSN	b6c5b5c0-b1cb-44c0-a849-5d317e6fa300	8
197320	allopurinol 300 MG Oral Tablet	SCD	b6c5b5c0-b1cb-44c0-a849-5d317e6fa300	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6572-61	00904657261	100 BLISTER PACK in 1 CARTON (0904-6572-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2003-06-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	Cardinal Health 107, LLC	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	9
Allopurinol	Major Pharmaceuticals	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	12