Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE TABLETS
Approved
Approval ID
2e04ce38-7f44-49d1-9471-a0141631594e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benazepril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1148
Application NumberANDA078848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (14)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICONInactive
Code: Z4152N8IUI
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Benazepril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1150
Application NumberANDA078848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (13)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICONInactive
Code: Z4152N8IUI
Classification: IACT
Benazepril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1151
Application NumberANDA078848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SILICONInactive
Code: Z4152N8IUI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Benazepril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1149
Application NumberANDA078848
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (13)
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICONInactive
Code: Z4152N8IUI
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT