Allopurinol

Product NDC: 43063-976
Requested package NDC: 43063-976-30
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…`

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

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 · 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): 43063-976-30 ndc (product): 43063-976 ndc11 (package): 43063097630
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

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
43063-976-30	43063097630	30 TABLET in 1 BOTTLE, PLASTIC (43063-976-30)	30 tablet	2019-08-20	0000-00-00	No	No	Current