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Cefadroxil

Cefadroxil Capsules, USP Rx only

Approved
Approval ID

e09261f8-e8e3-89cb-e053-2995a90a0cc0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 3, 2022

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-2752
Application NumberANDA065352
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 3, 2022
Generic NameCefadroxil

INGREDIENTS (10)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CEFADROXILActive
Quantity: 500 mg in 1 1
Code: 280111G160
Classification: ACTIM
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Cefadroxil - FDA Approval | MedPath