Cefprozil
Cefprozil Tablets, USP Rx Only
Approved
Approval ID
b9111a81-07c4-4458-b994-a4ad504986d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2021
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-068
Application NumberANDA065340
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (14)
CEFPROZILActive
Quantity: 250 mg in 1 1
Code: 4W0459ZA4V
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Cefprozil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-069
Application NumberANDA065340
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (12)
CEFPROZILActive
Quantity: 500 mg in 1 1
Code: 4W0459ZA4V
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT