Cefprozil
Cefprozil Tablets USP Rx only
Approved
Approval ID
3391de8b-7bc9-4624-a5c4-836135b39d99
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2018
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
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 Code0093-1078
Application NumberANDA065208
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2018
FDA Product Classification
INGREDIENTS (9)
CEFPROZILActive
Quantity: 500 mg in 1 1
Code: 4W0459ZA4V
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
Cefprozil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-1077
Application NumberANDA065208
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2018
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CEFPROZILActive
Quantity: 250 mg in 1 1
Code: 4W0459ZA4V
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT