MedPath

Cefadroxil

Cefadroxil

Approved
Approval ID

f6ddd84a-4a44-7035-e053-6294a90a6606

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 2, 2023

Manufacturers
FDA

Direct_Rx

DUNS: 079254320

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cefadroxil

PRODUCT DETAILS

NDC Product Code72189-445
Application NumberANDA065392
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 2, 2023
Generic NameCefadroxil

INGREDIENTS (13)

D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIM
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
© Copyright 2025. All Rights Reserved by MedPath
Cefadroxil - FDA Approval | MedPath