Lotensin HCT
Lotensin HCT
Approved
Approval ID
94c4536f-e28e-48b1-8336-b3939917e99d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Validus Pharmaceuticals LLC
DUNS: 801194619
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
benazepril hydrochloride and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-452
Application NumberNDA020033
Product Classification
M
Marketing Category
C73594
G
Generic Name
benazepril hydrochloride and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (10)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
benazepril hydrochloride and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-453
Application NumberNDA020033
Product Classification
M
Marketing Category
C73594
G
Generic Name
benazepril hydrochloride and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (10)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
benazepril hydrochloride and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-454
Application NumberNDA020033
Product Classification
M
Marketing Category
C73594
G
Generic Name
benazepril hydrochloride and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (10)
BENAZEPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT