BENAZEPRIL HYDROCHLORIDE - benazepril hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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BENAZEPRIL HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1148-9

Benazepril Hydrochloride Tablets, 5 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets

NDC 70771-1149-9

Benazepril Hydrochloride Tablets, 10 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets

NDC 70771-1150-9

Benazepril Hydrochloride Tablets, 20 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets

NDC 70771-1151-9

Benazepril Hydrochloride Tablets, 40 mg

90 Tablets

Rx only

Benazepril Hydrochloride Tablets
BENAZEPRIL HYDROCHLORIDE 
benazepril hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1148
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON (UNII: Z4152N8IUI)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code B1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1148-990 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
2NDC:70771-1148-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
3NDC:70771-1148-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07884811/13/2017
BENAZEPRIL HYDROCHLORIDE 
benazepril hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON (UNII: Z4152N8IUI)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code B2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1149-990 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
2NDC:70771-1149-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
3NDC:70771-1149-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
4NDC:70771-1149-4100 in 1 CARTON11/13/2017
4NDC:70771-1149-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07884811/13/2017
BENAZEPRIL HYDROCHLORIDE 
benazepril hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON (UNII: Z4152N8IUI)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code B3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1150-990 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
2NDC:70771-1150-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
3NDC:70771-1150-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
4NDC:70771-1150-4100 in 1 CARTON11/13/2017
4NDC:70771-1150-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07884811/13/2017
BENAZEPRIL HYDROCHLORIDE 
benazepril hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1151
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703) BENAZEPRIL HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON (UNII: Z4152N8IUI)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code B4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1151-990 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
2NDC:70771-1151-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
3NDC:70771-1151-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2017
4NDC:70771-1151-4100 in 1 CARTON11/13/2017
4NDC:70771-1151-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07884811/13/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1148, 70771-1149, 70771-1150, 70771-1151) , MANUFACTURE(70771-1148, 70771-1149, 70771-1150, 70771-1151)

Revised: 11/2022
Document Id: 5858760b-c49d-45f3-865a-ddb5533bdc68
Set id: 2e04ce38-7f44-49d1-9471-a0141631594e
Version: 5
Effective Time: 20221105
 
Zydus Lifesciences Limited