Cefadroxil
Cefadroxil Capsules USP 500 mg
Approved
Approval ID
7d49a2f4-c2b9-4127-82df-092da20a35d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-428
Application NumberANDA065392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefadroxil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification
INGREDIENTS (13)
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT