Allopurinol

Product NDC: 0603-2115
11-digit product format: 006032115
Labeler code: 0603
Product ID: 0603-2115_bb93f828-90b4-4844-9256-f4f964243818
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA075798
Marketing category: ANDA
Marketing start: 2003-06-27
Substance: ALLOPURINOL
Active strength: 100 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

Additional Listing Data#

Finished product: Yes
Brand name base: Allopurinol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	63CZ7GJN5I

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
0603-2115-02	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-02	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-04	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-04	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-21	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-21	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-28	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-28	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-32	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-32	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-93	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-93	2022-09-16	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-02	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-02	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-04	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-04	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-21	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-21	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-28	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-28	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-32	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-32	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-93	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-93	2022-07-29	C162847	48780-1	e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0603-2115-02	Allopurinol	90 in 1 BOTTLE, PLASTIC	TABLET	90	34
0603-2115-04	Allopurinol	180 in 1 BOTTLE, PLASTIC	TABLET	180	34
0603-2115-21	Allopurinol	100 in 1 BOTTLE, PLASTIC	TABLET	100	34
0603-2115-28	Allopurinol	500 in 1 BOTTLE, PLASTIC	TABLET	500	34
0603-2115-32	Allopurinol	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	34
0603-2115-93	Allopurinol	3000 in 1 BOTTLE, PLASTIC	TABLET	3000	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-2115-02	EA - Each	0603-2115	23d1fa4f-faba-4a6a-b810-5a803b4c3d2c	1	2012-07-24
0603-2115-04	EA - Each	0603-2115	e6f5f42c-1b75-4e25-98a3-35a3f625a324	1	2012-07-24
0603-2115-21	EA - Each	0603-2115	1d81a29d-c01d-44f9-adca-33e0273b0391	1	2012-07-24
0603-2115-32	EA - Each	0603-2115	150bb196-6537-4d61-8a68-8b7acf8d3dc6	1	2012-07-24
0603-2115-93	EA - Each	0603-2115	b03ad957-edf1-46cc-99f2-b62fb5e81fd6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]	10
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	2
ALLOPURINOL	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [STAT RX USA LLC]	1
ALLOPURINOL	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLOPURINOL TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLOPURINOL TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLOPURINOL TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ALLOPURINOL TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-2115	ALLOPURINOL TABLET [ENDO USA, INC.]	33	Current NDC, Legacy NDC, 6 package rows	20241212_fbac3b4f-dc23-4359-ac3f-2b3fdde41af2.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	f91c2183-e41d-45bc-87aa-edfca5eebac5	105
197319	allopurinol 100 MG Oral Tablet	SCD	f91c2183-e41d-45bc-87aa-edfca5eebac5	105
197319	allopurinol 100 MG Oral Tablet	PSN	90912dd4-5abf-4fd3-8fc1-3afd057b743f	103
197319	allopurinol 100 MG Oral Tablet	SCD	90912dd4-5abf-4fd3-8fc1-3afd057b743f	103
197319	allopurinol 100 MG Oral Tablet	PSN	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	36
197320	allopurinol 300 MG Oral Tablet	PSN	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	36
197319	allopurinol 100 MG Oral Tablet	SCD	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	36
197320	allopurinol 300 MG Oral Tablet	SCD	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	36
197319	allopurinol 100 MG Oral Tablet	PSN	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	34
197320	allopurinol 300 MG Oral Tablet	PSN	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	34
197319	allopurinol 100 MG Oral Tablet	SCD	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	34
197320	allopurinol 300 MG Oral Tablet	SCD	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	34
197319	allopurinol 100 MG Oral Tablet	PSN	4fe4f58d-975d-1f7d-e054-00144ff8d46c	3
197319	allopurinol 100 MG Oral Tablet	SCD	4fe4f58d-975d-1f7d-e054-00144ff8d46c	3
197319	allopurinol 100 MG Oral Tablet	PSN	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197320	allopurinol 300 MG Oral Tablet	PSN	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197319	allopurinol 100 MG Oral Tablet	SCD	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197320	allopurinol 300 MG Oral Tablet	SCD	548f6fbb-155f-45ff-ab44-0a70adad4424	2
197319	allopurinol 100 MG Oral Tablet	PSN	57fa94ed-b29c-456a-e053-2a91aa0af484	1
197319	allopurinol 100 MG Oral Tablet	PSN	8afe0c86-00c5-452f-b7b4-7ae81b7da131	1
197319	allopurinol 100 MG Oral Tablet	PSN	266cb5ff-bf9d-99bb-e063-6394a90a8f54	1
197319	allopurinol 100 MG Oral Tablet	SCD	57fa94ed-b29c-456a-e053-2a91aa0af484	1
197319	allopurinol 100 MG Oral Tablet	SCD	8afe0c86-00c5-452f-b7b4-7ae81b7da131	1
197319	allopurinol 100 MG Oral Tablet	SCD	266cb5ff-bf9d-99bb-e063-6394a90a8f54	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2115-02	00603211502	90 in 1 BOTTLE, PLASTIC						Historical
0603-2115-04	00603211504	180 in 1 BOTTLE, PLASTIC						Historical
0603-2115-21	00603211521	100 TABLET in 1 BOTTLE, PLASTIC (0603-2115-21)	100 tablet	2003-06-27	0000-00-00	No	No	Current
0603-2115-28	00603211528	500 in 1 BOTTLE, PLASTIC						Historical
0603-2115-32	00603211532	1000 TABLET in 1 BOTTLE, PLASTIC (0603-2115-32)	1000 tablet	2003-06-27	0000-00-00	No	No	Current
0603-2115-93	00603211593	3000 in 1 BOTTLE, PLASTIC						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	NCS HealthCare of KY, LLC dba Vangard Labs	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	36
Allopurinol	REMEDYREPACK INC.	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	8
Allopurinol	Coupler LLC	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol	Bryant Ranch Prepack	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	105
Allopurinol	Bryant Ranch Prepack	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	103
Allopurinol	Par Health USA, LLC \| Generics Bidco II LLC d/b/a Prinston Laboratories \| Par Formulations Private Limited	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	34
Allopurinol - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
ALLOPURINOL 100 mg 008-30	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-08-30	HUMAN PRESCRIPTION DRUG LABEL	1
ALLOPURINOL 100 mg Scored Tablets and 300 mg Scored Tablets	Aphena Pharma Solutions - Tennessee, Inc. \| Vintage Pharmaceuticals-Charlotte \| Vintage Pharmaceuticals-Huntsville	2012-03-26	HUMAN PRESCRIPTION DRUG LABEL	2
ALLOPURINOL 100 mg Scored Tablets	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL	1

Allopurinol

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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#