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Fosinopril Sodium

FOSINOPRIL SODIUM TABLETS 10 mg, 20 mg and 40 mg Rx only

Approved
Approval ID

2f122ad0-f9c2-4c90-a94b-072354b876b5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 25, 2011

Manufacturers
FDA

Unit Dose Services

DUNS: 831995316

Products 1

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 Code50436-0274
Application NumberANDA077222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2011
FDA Product Classification

INGREDIENTS (6)

FOSINOPRIL SODIUMActive
Quantity: 40 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT

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Fosinopril Sodium - FDA Drug Approval Details