FEBUXOSTAT- febuxostat tablet 
Zydus Lifesciences Limited

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Febuxostat Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Febuxostat Tablets, 40 mg – 30's count

NDC- 70771-1552-3

40 mg label

Febuxostat Tablets, 80 mg – 30's count

NDC- 70771-1553-3

80 mg label
FEBUXOSTAT 
febuxostat tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1552
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E) FEBUXOSTAT40 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code 401
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1552-330 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
2NDC:70771-1552-990 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
3NDC:70771-1552-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
4NDC:70771-1552-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
5NDC:70771-1552-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
6NDC:70771-1552-410 in 1 CARTON03/31/2023
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20544303/31/2023
FEBUXOSTAT 
febuxostat tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1553
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E) FEBUXOSTAT80 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code 402
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1553-330 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
2NDC:70771-1553-990 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
3NDC:70771-1553-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
4NDC:70771-1553-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
5NDC:70771-1553-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
6NDC:70771-1553-410 in 1 CARTON03/31/2023
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20544303/31/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1552, 70771-1553) , MANUFACTURE(70771-1552, 70771-1553)

Revised: 10/2023
Document Id: 4c93b558-a741-4ffc-b061-21e98465a727
Set id: 0629ab39-196e-4198-902a-3c16277ba205
Version: 2
Effective Time: 20231004
 
Zydus Lifesciences Limited