MedPath

CEFPROZIL

Cefprozil Tablets

Approved
Approval ID

0f96e4fe-8daf-492b-8fd8-90ff25243077

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 7, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

Products 1

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

CEFPROZIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-0590
Application NumberANDA065276
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFPROZIL
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2011
FDA Product Classification

INGREDIENTS (6)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEFPROZILActive
Quantity: 500 mg in 1 1
Code: 4W0459ZA4V
Classification: ACTIM
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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CEFPROZIL - FDA Drug Approval Details