Allopurinol

Product NDC: 0591-5543
11-digit product format: 005915543
Labeler code: 0591
Product ID: 0591-5543_f7e04d88-1d9b-47e6-a9ad-deb08af3c098
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA018832
Marketing category: NDA
Marketing start: 2009-04-06
Marketing end: 2027-04-30
Substance: ALLOPURINOL
Active strength: 100 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Allopurinol

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	63CZ7GJN5I
Rxcui	197319, 197320

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	Strength	SPL version
0591-5543-01	Allopurinol	100 in 1 BOTTLE, PLASTIC	TABLET	100		16
0591-5543-10	Allopurinol	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-5543-01	EA - Each	0591-5543	4902afaa-fd1e-4b4d-bc65-83052b01ef96	1	2012-07-24
0591-5543-10	EA - Each	0591-5543	98fc485a-436e-4b89-9973-3bbcfd1a7d20	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]	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
0591-5543	ALLOPURINOL TABLET [ACTAVIS PHARMA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240606_a80fe56f-8d03-423f-8e2a-7ec8c9e5045b.zip

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	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	16
197320	allopurinol 300 MG Oral Tablet	PSN	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	16
197319	allopurinol 100 MG Oral Tablet	SCD	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	16
197320	allopurinol 300 MG Oral Tablet	SCD	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	16
197319	allopurinol 100 MG Oral Tablet	PSN	632baede-6ade-450e-afa3-50a6cf1f9c91	10
197320	allopurinol 300 MG Oral Tablet	PSN	632baede-6ade-450e-afa3-50a6cf1f9c91	10
197319	allopurinol 100 MG Oral Tablet	SCD	632baede-6ade-450e-afa3-50a6cf1f9c91	10
197320	allopurinol 300 MG Oral Tablet	SCD	632baede-6ade-450e-afa3-50a6cf1f9c91	10
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
197319	allopurinol 100 MG Oral Tablet	PSN	4fa7df0b-78ee-4bad-e054-00144ff8d46c	3
197319	allopurinol 100 MG Oral Tablet	SCD	4fa7df0b-78ee-4bad-e054-00144ff8d46c	3
197319	allopurinol 100 MG Oral Tablet	PSN	e1f42971-8169-4053-9857-585cef2ba7b0	2
197320	allopurinol 300 MG Oral Tablet	PSN	e1f42971-8169-4053-9857-585cef2ba7b0	2
197319	allopurinol 100 MG Oral Tablet	SCD	e1f42971-8169-4053-9857-585cef2ba7b0	2
197320	allopurinol 300 MG Oral Tablet	SCD	e1f42971-8169-4053-9857-585cef2ba7b0	2
197319	allopurinol 100 MG Oral Tablet	PSN	c9a01871-bbf8-4b31-9b9b-9fa8c0997b29	1
197319	allopurinol 100 MG Oral Tablet	PSN	da5833e4-1a6a-4978-bc9e-3045f774922a	1
197319	allopurinol 100 MG Oral Tablet	PSN	c87fceaa-0e56-4042-95a2-08e7c0d6bc47	1
197319	allopurinol 100 MG Oral Tablet	PSN	a0c9fff0-f0ba-4bfe-ac88-afbfe31fcf68	1
197320	allopurinol 300 MG Oral Tablet	PSN	da5833e4-1a6a-4978-bc9e-3045f774922a	1
197320	allopurinol 300 MG Oral Tablet	PSN	c87fceaa-0e56-4042-95a2-08e7c0d6bc47	1
197320	allopurinol 300 MG Oral Tablet	PSN	a0c9fff0-f0ba-4bfe-ac88-afbfe31fcf68	1
197319	allopurinol 100 MG Oral Tablet	SCD	c87fceaa-0e56-4042-95a2-08e7c0d6bc47	1
197319	allopurinol 100 MG Oral Tablet	SCD	c9a01871-bbf8-4b31-9b9b-9fa8c0997b29	1
197319	allopurinol 100 MG Oral Tablet	SCD	da5833e4-1a6a-4978-bc9e-3045f774922a	1
197319	allopurinol 100 MG Oral Tablet	SCD	a0c9fff0-f0ba-4bfe-ac88-afbfe31fcf68	1
197320	allopurinol 300 MG Oral Tablet	SCD	a0c9fff0-f0ba-4bfe-ac88-afbfe31fcf68	1
197320	allopurinol 300 MG Oral Tablet	SCD	da5833e4-1a6a-4978-bc9e-3045f774922a	1
197320	allopurinol 300 MG Oral Tablet	SCD	c87fceaa-0e56-4042-95a2-08e7c0d6bc47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-5543-01	00591554301	100 TABLET in 1 BOTTLE, PLASTIC (0591-5543-01)	100 tablet	2009-04-06	2026-05-31	No	No	Current
0591-5543-10	00591554310	1000 TABLET in 1 BOTTLE, PLASTIC (0591-5543-10)	1000 tablet	2009-04-06	2027-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	Actavis Pharma, Inc.	2024-04-01	HUMAN PRESCRIPTION DRUG LABEL	16
Allopurinol Tablets USP Revised: March 2009 Rx only 184001	Proficient Rx LP	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	6
Allopurinol - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Allopurinol Tablets USP Rx only	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	10
Allopurinol Tablets USP Revised: February 2015 Rx only	Aidarex Pharmaceuticals LLC	2017-02-24	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol Tablets USP Revised: March 2009 Rx only 184001	Aidarex Pharmaceuticals LLC	2013-11-14	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-06-08	HUMAN PRESCRIPTION DRUG LABEL	2
Allopurinol Tablets USP Rx only	State of Florida DOH Central Pharmacy	2010-06-07	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol Tablets USP	Rebel Distributors Corp.	2009-06-01	HUMAN PRESCRIPTION DRUG LABEL	1

Allopurinol

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#