Allopurinol

Product NDC: 69315-292
Requested package NDC: 69315-292-10
11-digit product format: 693150292
Labeler code: 69315
Product ID: 69315-292_227ef709-80a3-45e9-807a-2db8abee3a50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA214443
Marketing category: ANDA
Marketing start: 2024-05-01
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 43.

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
A214443-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07
A214443-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07
A214443-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214443-001	AB
A214443-002	AB
A214443-003	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 · 81 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
2026-09-14 22:38:34	2026-08	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214443-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214443-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214443-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214443-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214443-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214443-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214443-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214443-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214443-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Allopurinol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	300 mg/1

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	SPL version
69315-292-01	Allopurinol	100 in 1 BOTTLE	TABLET	100	11
69315-292-05	Allopurinol	500 in 1 BOTTLE	TABLET	500	11
69315-292-10	Allopurinol	1000 in 1 BOTTLE	TABLET	1000	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-292-01	EA - Each	69315-292	5481548a-431f-4d44-8dfa-274fb3f2c96e	1	2023-07-06
69315-292-05	EA - Each	69315-292	fe6ee816-926e-45a6-ba94-9f7339d87f30	1	2023-07-06
69315-292-10	EA - Each	69315-292	0d047b80-00f9-4f95-a3fb-a56693b5cbdb	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-292	ALLOPURINOL TABLET [LEADING PHARMA, LLC]	11	Current NDC, 3 package rows	20240926_f2e8b7fc-936c-585d-e053-2a95a90a1d6c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	92d9a9d1-76c0-4435-984d-48f44b452855	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	b3b9dcf4-cada-4f79-befc-319c7dff15eb	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Coupler LLC	47b8c920-4648-604e-e063-6294a90a1f54	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	ST. MARY'S MEDICAL PARK PHARMACY	42de3b18-a289-e49e-e063-6394a90a89d4	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	3f0134bf-b62f-1077-e063-6394a90a60b0	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	2f27f578-f965-04c9-e063-6394a90a1ae2	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Harman Finochem Limited	0780dc78-d287-d5db-e063-6294a90aa1dd	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	92253e70-0b0c-4a0c-9bd6-ccea91000819	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	20eef55e-0d70-874b-e063-6394a90aa06a	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443

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
197319	allopurinol 100 MG Oral Tablet	PSN	f2e8b7fc-936c-585d-e053-2a95a90a1d6c	11
245422	allopurinol 200 MG Oral Tablet	PSN	f2e8b7fc-936c-585d-e053-2a95a90a1d6c	11
197320	allopurinol 300 MG Oral Tablet	PSN	f2e8b7fc-936c-585d-e053-2a95a90a1d6c	11
197319	allopurinol 100 MG Oral Tablet	SCD	f2e8b7fc-936c-585d-e053-2a95a90a1d6c	11
245422	allopurinol 200 MG Oral Tablet	SCD	f2e8b7fc-936c-585d-e053-2a95a90a1d6c	11
197320	allopurinol 300 MG Oral Tablet	SCD	f2e8b7fc-936c-585d-e053-2a95a90a1d6c	11
197320	allopurinol 300 MG Oral Tablet	PSN	92d9a9d1-76c0-4435-984d-48f44b452855	3
197320	allopurinol 300 MG Oral Tablet	SCD	92d9a9d1-76c0-4435-984d-48f44b452855	3
197320	allopurinol 300 MG Oral Tablet	PSN	47b8c920-4648-604e-e063-6294a90a1f54	2
197320	allopurinol 300 MG Oral Tablet	SCD	47b8c920-4648-604e-e063-6294a90a1f54	2
197320	allopurinol 300 MG Oral Tablet	PSN	20eef55e-0d70-874b-e063-6394a90aa06a	1
197320	allopurinol 300 MG Oral Tablet	SCD	20eef55e-0d70-874b-e063-6394a90aa06a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69315-292-10	69315029210	1000 TABLET in 1 BOTTLE (69315-292-10)	1000 tablet	2024-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	Preferred Pharmaceuticals Inc.	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	3
Allopurinol	Coupler LLC	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Allopurinol	Leading Pharma, LLC \| Harman Finochem Limited	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL	11
Allopurinol	NuCare Pharmaceuticals, Inc.	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	1