Cefpodoxime Proxetil
Approved
Approval ID
5310de78-22c3-4bee-9956-854e767b6bef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefpodoxime Proxetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-402
Application NumberANDA065409
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefpodoxime Proxetil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CEFPODOXIME PROXETILActive
Quantity: 50 mg in 5 mL
Code: 2TB00A1Z7N
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
Cefpodoxime Proxetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-403
Application NumberANDA065409
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefpodoxime Proxetil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (13)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CEFPODOXIME PROXETILActive
Quantity: 100 mg in 5 mL
Code: 2TB00A1Z7N
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT