CEFPROZIL
CEFPROZIL TABLETS USP 250 mg and 500 mgRx only
Approved
Approval ID
17a1975e-ce3b-4057-ae5b-8d191319caa7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2011
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.
CEFPROZIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-300
Application NumberANDA065276
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFPROZIL
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2011
FDA Product Classification
INGREDIENTS (6)
CEFPROZILActive
Quantity: 500 mg in 1 1
Code: 4W0459ZA4V
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT