Cefpodoxime Proxetil
Approved
Approval ID
849a91fa-6412-4985-a567-528c508e6815
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2022
Manufacturers
FDA
Amici Pharmaceuticals, LLC.
DUNS: 079536824
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 Code69292-512
Application NumberANDA210568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefpodoxime Proxetil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2022
FDA Product Classification
INGREDIENTS (14)
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEFPODOXIME PROXETILActive
Quantity: 200 mg in 1 1
Code: 2TB00A1Z7N
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Cefpodoxime Proxetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-510
Application NumberANDA210568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefpodoxime Proxetil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2022
FDA Product Classification
INGREDIENTS (14)
CEFPODOXIME PROXETILActive
Quantity: 100 mg in 1 1
Code: 2TB00A1Z7N
Classification: ACTIM
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT