Allopurinol

Product NDC: 16714-577
11-digit product format: 167140577
Labeler code: 16714
Product ID: 16714-577_0f560d11-3ba5-4dd4-8c20-ed9b43bfd69a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA204467
Marketing category: ANDA
Marketing start: 2022-07-01
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	300 mg/1

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

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-577-01	Allopurinol	100 in 1 BOTTLE	TABLET	100		5
16714-577-02	Allopurinol	500 in 1 BOTTLE	TABLET	500		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-577	ALLOPURINOL TABLET [NORTHSTAR RXLLC]	5	Current NDC, Legacy NDC, 2 package rows	20240915_95a1ca8c-9855-4b11-92cd-6fdc144f0d3b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63CZ7GJN5I	ALLOPURINOL	315-30-0	ALLOPURINOL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197319	allopurinol 100 MG Oral Tablet	PSN	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	5
197320	allopurinol 300 MG Oral Tablet	PSN	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	5
197319	allopurinol 100 MG Oral Tablet	SCD	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	5
197320	allopurinol 300 MG Oral Tablet	SCD	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	5
197320	allopurinol 300 MG Oral Tablet	PSN	420d338d-4d0d-4e38-bfe2-a83256821b45	3
197320	allopurinol 300 MG Oral Tablet	PSN	7bf1be4e-72ba-407c-90b3-b70b09a25d6e	3
197320	allopurinol 300 MG Oral Tablet	SCD	420d338d-4d0d-4e38-bfe2-a83256821b45	3
197320	allopurinol 300 MG Oral Tablet	SCD	7bf1be4e-72ba-407c-90b3-b70b09a25d6e	3
197320	allopurinol 300 MG Oral Tablet	PSN	52ce5aab-76cf-465d-8f14-c745d382cd15	1
197320	allopurinol 300 MG Oral Tablet	PSN	a5c35283-09d2-4bb4-bdd1-055035fa272b	1
197320	allopurinol 300 MG Oral Tablet	SCD	52ce5aab-76cf-465d-8f14-c745d382cd15	1
197320	allopurinol 300 MG Oral Tablet	SCD	a5c35283-09d2-4bb4-bdd1-055035fa272b	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-577-01	16714057701	100 TABLET in 1 BOTTLE (16714-577-01)	100 tablet	2022-07-01	0000-00-00	No	No	Current
16714-577-02	16714057702	500 TABLET in 1 BOTTLE (16714-577-02)	500 tablet	2022-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	REMEDYREPACK INC.	2026-01-27	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol	NorthStar RxLLC \| INDOCO REMEDIES LIMITED	2024-09-13	Human Prescription Drug Label	5
Allopurinol	A-S Medication Solutions	2024-04-10	Human Prescription Drug Label	3
Allopurinol	A-S Medication Solutions	2024-04-10	Human Prescription Drug Label	3
ALLOPURINOL TABLETS USP 100 mg and 300 mg Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2022-12-13	Human Prescription Drug Label	1