Fosinopril Sodium
FOSINOPRILSODIUM TABLETS, USP 10mg, 20mg and 40mg Rx Only
Approved
Approval ID
c0915c29-f4c8-4915-8a73-3714e39aa26d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
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 Code68788-7717
Application NumberANDA077222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (6)
FOSINOPRIL SODIUMActive
Quantity: 20 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT