Cefadroxil
Cefadroxil Capsules USP 500 mg
Approved
Approval ID
691e3784-84bf-4e7f-e053-2991aa0a5a24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2020
Manufacturers
FDA
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
DUNS: 080355546
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefadroxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70934-081
Application NumberANDA065392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefadroxil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (13)
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIM