Allopurinol

Product NDC: 43063-976
Requested package NDC: 43063-976-90
11-digit product format: 430630976
Labeler code: 43063
Product ID: 43063-976_415f7734-80d6-97e2-e063-6294a90aaa45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA071450
Marketing category: ANDA
Marketing start: 1987-01-09
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071450-001	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		1987-01-09
A071450-002	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		1987-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A071450-001	AB
A071450-002	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 · 82 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	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A071450-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071450-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071450-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071450-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071450-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071450-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071450-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071450-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071450-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071450-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071450-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071450-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071450-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071450-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071450-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071450-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071450-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071450-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071450-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071450-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071450-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071450-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071450-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071450-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071450-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071450-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071450-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071450-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071450-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071450-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071450-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071450-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071450-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071450-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071450-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071450-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071450-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071450-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071450-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071450-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	156d743c-6324-44db-9230-21f762d64cfd	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	b2ab2389-ccaf-487b-9985-50e3539e7617	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	211e47c6-85b9-43e8-9e07-6cc4b8f708a0	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450 ndc (package): 43063-976-90 ndc (product): 43063-976 ndc11 (package): 43063097690
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	f1c11f74-1de2-484c-b40b-d0013e8fd01a	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	f130c9c0-45d8-42bc-a040-04bb077671f8	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Sun Pharmaceutical Industries, Inc.	fd8f8b8b-f25e-46e9-969a-65363b66e09b	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	df745f5f-7f05-205d-e053-2995a90a05a4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	f67d4aa7-6e5f-bba1-e053-2a95a90a1194	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Proficient Rx LP	b20c6ed4-6b94-4a1b-b448-e910856fa825	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Proficient Rx LP	06cf0f4b-aef0-472e-b5c0-56e0c35354f2	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	bb8f09b6-c9f5-4deb-81e1-8d743e622126	2019-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	3f5905f1-243e-4880-ad1c-d34064f17356	2019-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450

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
211e47c6-85b9-43e8-9e07-6cc4b8f708a0	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
43063-976-30	Allopurinol	30 in 1 BOTTLE, PLASTIC	TABLET	30		16
43063-976-90	Allopurinol	90 in 1 BOTTLE, PLASTIC	TABLET	90		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-976-30	EA - Each	43063-976	c8360510-48a8-4a19-9e30-6402218e505f	1	2019-10-07
43063-976-90	EA - Each	43063-976	3fb768c1-2ff6-419b-a9b1-541e6efc1426	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-976	ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240713_211e47c6-85b9-43e8-9e07-6cc4b8f708a0.zip

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	211e47c6-85b9-43e8-9e07-6cc4b8f708a0	17
197320	allopurinol 300 MG Oral Tablet	SCD	211e47c6-85b9-43e8-9e07-6cc4b8f708a0	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-976-90	43063097690	90 TABLET in 1 BOTTLE, PLASTIC (43063-976-90)	90 tablet	2019-04-29	0000-00-00	No	No	Current