Fosinopril Sodium
FOSINOPRIL SODIUM TABLETS USP, 10 mg, 20 mg, and 40 mg 722272237224Rx only
Approved
Approval ID
e8c794ba-8a15-4e3e-ba3b-1704887628cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 5, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5055
Application NumberANDA076139
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2013
FDA Product Classification
INGREDIENTS (8)
FOSINOPRIL SODIUMActive
Quantity: 20 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5182
Application NumberANDA076139
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2013
FDA Product Classification
INGREDIENTS (8)
FOSINOPRIL SODIUMActive
Quantity: 40 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5064
Application NumberANDA076139
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2013
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FOSINOPRIL SODIUMActive
Quantity: 10 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT