ENTECAVIR- entecavir tablet, film coated 
Zydus Lifesciences Limited

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ENTECAVIR TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1019-3

Entecavir Tablets USP, 0.5 mg

Rx Only

30 tablets

Entecavir tablets

NDC 70771-1020-3

Entecavir Tablets USP, 1 mg

Rx Only

30 tablets

Entecavir tablets
ENTECAVIR 
entecavir tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENTECAVIR (UNII: 5968Y6H45M) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D) ENTECAVIR0.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 920
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1019-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
2NDC:70771-1019-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
3NDC:70771-1019-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
4NDC:70771-1019-410 in 1 CARTON08/10/2017
4NDC:70771-1019-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20674508/10/2017
ENTECAVIR 
entecavir tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENTECAVIR (UNII: 5968Y6H45M) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D) ENTECAVIR1 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (LIGHT-PINK TO PINK) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 921
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1020-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
2NDC:70771-1020-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
3NDC:70771-1020-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
4NDC:70771-1020-410 in 1 CARTON08/10/2017
4NDC:70771-1020-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20674508/10/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1019, 70771-1020) , MANUFACTURE(70771-1019, 70771-1020)

Revised: 11/2024
Document Id: eb274d01-4108-4d2e-8e2b-8656b90684c0
Set id: 0e3b2a0a-9076-4907-bbaf-eb6a65bb9481
Version: 6
Effective Time: 20241128
 
Zydus Lifesciences Limited