Allopurinol

Product NDC: 68788-7542
Requested package NDC: 68788-7542-3
11-digit product format: 687887542
Labeler code: 68788
Product ID: 68788-7542_e5d27cfb-5f0a-4237-b937-b6db6f9f9028
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA210117
Marketing category: ANDA
Marketing start: 2018-02-08
Marketing end: 0000-00-00
Substance: ALLOPURINOL
Active strength: 300 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7542	68788-7542-3	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210117-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12
A210117-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12
A210117-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210117-001	AB
A210117-002	AB
A210117-003	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 · 89 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	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 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	A210117-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210117-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210117-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210117-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210117-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210117-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210117-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210117-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210117-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210117-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210117-002	AB	1	`4b0b4de00fa7…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68788-7542-1	2023-01-30	C162847	48780-1	f386c649-9f25-0266-e053-dadaa90a7c1a	Allopurinol Tablets USP Rx Only
68788-7542-3	2023-01-30	C162847	48780-1	f386c649-9f25-0266-e053-dadaa90a7c1a	Allopurinol Tablets USP Rx Only
68788-7542-9	2023-01-30	C162847	48780-1	f386c649-9f25-0266-e053-dadaa90a7c1a	Allopurinol Tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7542-1	Allopurinol	100 in 1 BOTTLE	TABLET	100	2
68788-7542-3	Allopurinol	30 in 1 BOTTLE	TABLET	30	2
68788-7542-9	Allopurinol	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7542-1	EA - Each	68788-7542	d4f2532d-02d0-4237-8985-8d3a758e34e7	1	2020-08-06
68788-7542-3	EA - Each	68788-7542	b700718d-9ac4-476e-877c-20638bae3f56	1	2020-08-06
68788-7542-9	EA - Each	68788-7542	95dc79ea-7ba5-4566-911a-648b1ce43b5d	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7542	ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS, INC.]	2	Legacy NDC, 3 package rows	20210224_0c4431bc-e514-4e89-9495-025a24f399d0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	b630c1cb-d4b7-4f80-b252-5947c1887def	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	2462b4b5-8313-4e4d-93ac-839de4a29520	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117
Allopurinol	ALLOPURINOL	Zydus Lifesciences Limited	9232f484-a5f6-4c63-b7f4-b510d2827159	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117
Allopurinol	ALLOPURINOL	Zydus Pharmaceuticals (USA) Inc.	8b926e62-3a9c-424a-833a-8169e55a1f15	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117

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	0c4431bc-e514-4e89-9495-025a24f399d0	2
197320	allopurinol 300 MG Oral Tablet	SCD	0c4431bc-e514-4e89-9495-025a24f399d0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7542-3	68788754203	30 TABLET in 1 BOTTLE (68788-7542-3)	30 tablet	2019-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol Tablets USP Rx Only	Preferred Pharmaceuticals, Inc.	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	2