Benazepril Hydrochloride
BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 mg, 10 mg, 20 mg and 40 mg5124512551265127Rx only
Approved
Approval ID
cb3c47b7-4f27-40a0-ac8b-c4df0b100909
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5079
Application NumberANDA076211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (15)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5204
Application NumberANDA076211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (14)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5392
Application NumberANDA076211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (14)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5001
Application NumberANDA076211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (13)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT