Fosinopril sodium
Fosinopril Sodium Tablets, USP, for oral use Rx only
Approved
Approval ID
3d521d4d-29f8-40d7-971b-0efb68dfbff2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 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.
fosinopirl sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0726
Application NumberANDA205670
Product Classification
M
Marketing Category
C73584
G
Generic Name
fosinopirl sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2017
FDA Product Classification
INGREDIENTS (6)
FOSINOPRIL SODIUMActive
Quantity: 10 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT