Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosinopril Sodium
Product Details
NDC Product Code
54868-5055Application Number
ANDA076139Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2013FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 20 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
Fosinopril Sodium
Product Details
NDC Product Code
54868-5182Application Number
ANDA076139Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2013FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 40 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
Fosinopril Sodium
Product Details
NDC Product Code
54868-5064Application Number
ANDA076139Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 5, 2013CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 10 mg in 1 1
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT