Allopurinol

Product NDC: 63187-240
Requested package NDC: 63187-240-90
11-digit product format: 631870240
Labeler code: 63187
Product ID: 63187-240_dc8eb4a8-0fb0-4964-9d48-b299f99744f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: NDA018877
Marketing category: NDA
Marketing start: 2009-04-06
Substance: ALLOPURINOL
Active strength: 300 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018877-001	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		1984-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018877-001	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 2 · 43 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	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	N018877-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018877-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018877-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018877-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018877-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018877-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018877-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018877-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018877-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018877-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018877-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018877-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018877-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018877-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018877-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018877-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018877-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018877-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018877-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018877-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018877-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018877-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018877-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018877-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018877-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018877-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018877-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018877-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018877-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018877-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018877-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018877-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018877-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018877-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018877-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018877-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018877-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018877-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018877-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018877-001	AB	1	`f41ea6bd6efb…`

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: 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197319	Internal RxNorm lookup
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
0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	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	SPL version
63187-240-30	Allopurinol	30 in 1 BOTTLE, PLASTIC	TABLET	30	6
63187-240-60	Allopurinol	60 in 1 BOTTLE, PLASTIC	TABLET	60	6
63187-240-90	Allopurinol	90 in 1 BOTTLE, PLASTIC	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-240-90	EA - Each	63187-240	8acd3092-301a-4fc3-9313-5aba65ffe599	1	2023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-240	ALLOPURINOL TABLET [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 3 package rows	20230225_0ca4baed-c5d8-4de4-ac17-6e5d1df15c03.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	Bryant Ranch Prepack	7003e410-b4ff-da07-5571-07e7e13f67e0	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877
Allopurinol	ALLOPURINOL	Actavis Pharma, Inc.	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877
Allopurinol	ALLOPURINOL	Proficient Rx LP	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877 ndc (package): 63187-240-90 ndc (product): 63187-240 ndc11 (package): 63187024090
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	9b0e3f11-c02a-443d-806f-134c907ea371	2022-12-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877

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	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	6
197320	allopurinol 300 MG Oral Tablet	PSN	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	6
197319	allopurinol 100 MG Oral Tablet	SCD	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	6
197320	allopurinol 300 MG Oral Tablet	SCD	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63187-240-90	63187024090	90 TABLET in 1 BOTTLE, PLASTIC (63187-240-90)	90 tablet	2023-02-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol Tablets USP Revised: March 2009 Rx only 184001	Proficient Rx LP	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	6