febuxostat by Zydus Lifesciences Limited FEBUXOSTAT tablet

febuxostat by

Drug Labeling and Warnings

febuxostat by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Febuxostat Tablets, 40 mg – 30's count

NDC- 70771-1552-3

Febuxostat Tablets, 80 mg – 30's count

NDC- 70771-1553-3

INGREDIENTS AND APPEARANCE

FEBUXOSTAT 
febuxostat tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1552
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E)	FEBUXOSTAT	40 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	401
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1552-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
2	NDC: 70771-1552-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
3	NDC: 70771-1552-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
4	NDC: 70771-1552-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
5	NDC: 70771-1552-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
6	NDC: 70771-1552-4	10 in 1 CARTON	03/31/2023
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205443	03/31/2023

FEBUXOSTAT 
febuxostat tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1553
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E)	FEBUXOSTAT	80 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	402
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1553-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
2	NDC: 70771-1553-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
3	NDC: 70771-1553-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
4	NDC: 70771-1553-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
5	NDC: 70771-1553-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2023
6	NDC: 70771-1553-4	10 in 1 CARTON	03/31/2023
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205443	03/31/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1552, 70771-1553) , MANUFACTURE(70771-1552, 70771-1553)