Allopurinol

Product NDC: 70518-1576
11-digit product format: 705181576
Labeler code: 70518
Product ID: 70518-1576_94778013-48b8-788c-e053-2995a90a66c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA071450
Marketing category: ANDA
Marketing start: 2018-10-23
Marketing end: 0000-00-00
Substance: ALLOPURINOL
Active strength: 100 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-1576		D	Discontinued by firm	2026-08-17
excluded package	package	70518-1576	70518-1576-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-1576	70518-1576-1	D	Discontinued by firm	2026-08-17
excluded package	package	70518-1576	70518-1576-2	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 25 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1576-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1576-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1576-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1576-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1576-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1576-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1576-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1576-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1576-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1576-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1576-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1576-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1576-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1576-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1576-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1576-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1576-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1576-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1576-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1576-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1576-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1576-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1576-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 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	A071450-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1987-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071450-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1987-01-09	`caaa826d4ba7…`
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…`

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	A071450-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071450-002	AB	1	`caaa826d4ba7…`
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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1576	ALLOPURINOL TABLET [REMEDYREPACK INC.]	9	Legacy NDC	20250226_9419c123-004e-41d4-915d-388c65a92d7d.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	PD-Rx Pharmaceuticals, Inc.	f1c11f74-1de2-484c-b40b-d0013e8fd01a	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	f130c9c0-45d8-42bc-a040-04bb077671f8	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	b2ab2389-ccaf-487b-9985-50e3539e7617	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	211e47c6-85b9-43e8-9e07-6cc4b8f708a0	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
Allopurinol	ALLOPURINOL	Sun Pharmaceutical Industries, Inc.	fd8f8b8b-f25e-46e9-969a-65363b66e09b	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071450 application number: ANDA071450
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	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