Cefprozil
Cefprozil for Oral Suspension, USP Rx only
Approved
Approval ID
97675251-70b8-43bc-93ea-f9ef6bb8cb68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 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 Code65862-099
Application NumberANDA065381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2021
FDA Product Classification
INGREDIENTS (13)
CEFPROZILActive
Quantity: 125 mg in 5 mL
Code: 4W0459ZA4V
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
Cefprozil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-100
Application NumberANDA065381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefprozil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2021
FDA Product Classification
INGREDIENTS (13)
CEFPROZILActive
Quantity: 250 mg in 5 mL
Code: 4W0459ZA4V
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT