Allopurinol

Product NDC: 0615-1592
Requested package NDC: 0615-1592-05
11-digit product format: 006151592
Labeler code: 0615
Product ID: 0615-1592_1d646bc4-27cc-4757-87de-75de028c10d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA018659
Marketing category: ANDA
Marketing start: 1986-10-24
Marketing end: 2021-07-31
Substance: ALLOPURINOL
Active strength: 100 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0615-1592	0615-1592-05	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A018659-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		1986-10-24
A018659-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		1986-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A018659-001	AB
A018659-002	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	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`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	A018659-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A018659-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A018659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A018659-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A018659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A018659-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A018659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A018659-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A018659-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A018659-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A018659-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A018659-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A018659-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A018659-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A018659-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A018659-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A018659-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A018659-002	AB	1	`bb7c543d1eb4…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2

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	Cardinal Health 107, LLC	ced59048-c147-4702-af32-2f9b517ed87a	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	1ce96b87-323d-40b6-a40b-32821e00d94c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	5dca2d4f-0e93-4d1a-8d9f-b9b72867c242	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Safecor Health, LLC	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	7c7eafa6-5411-470c-8a45-cfbc85d3e335	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Mylan Pharmaceuticals Inc.	bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	8f50e91e-66a7-4fd4-888a-9f1986aa661c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Mylan Institutional Inc.	994b3117-b83e-44d9-910c-1c3a26ef838e	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	15d758f9-2ec5-ecf5-e063-6394a90a7a2c	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Coupler LLC	65171cf0-8486-1ca6-e053-2991aa0ab91f	2018-04-18		Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	aea483a7-4ce7-4fe5-936c-fd876b4fa3a8	2017-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	ae821c68-626a-474c-b81d-ce75d9795b3c	2016-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63CZ7GJN5I	ALLOPURINOL	315-30-0	ALLOPURINOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-1592-05	00615159205	15 TABLET in 1 BLISTER PACK (0615-1592-05)	15 tablet	2006-05-31	2021-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol Tablets	NCS HealthCare of KY, Inc dba Vangard Labs	2016-07-12	HUMAN PRESCRIPTION DRUG LABEL	6