Fosinopril Sodium
FOSINOPRILSODIUM TABLETS, USP10mg, 20mg and 40mgRx Only
Approved
Approval ID
6562a532-b502-4515-88df-591d71293b56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0187
Application NumberANDA077222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2019
FDA Product Classification
INGREDIENTS (6)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FOSINOPRIL SODIUMActive
Quantity: 20 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT