SUPRAX
These highlights do not include all the information needed to use SUPRAX® safely and effectively. See full prescribing information for SUPRAX®. SUPRAX® (cefixime) tablets, for oral useSUPRAX® (cefixime) capsules, for oral useSUPRAX® (cefixime) chewable tablets, for oral useSUPRAX® (cefixime) for oral suspension Initial U.S. Approval: 1986
Approved
Approval ID
d0fd45bd-7d52-4fa6-a5f7-f46d5651ffa2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cefixime
PRODUCT DETAILS
NDC Product Code27437-203
Application NumberANDA065380
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Namecefixime
INGREDIENTS (9)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CEFIXIMEActive
Quantity: 100 mg in 1 1
Code: 97I1C92E55
Classification: ACTIM
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
cefixime
PRODUCT DETAILS
NDC Product Code27437-205
Application NumberANDA065380
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Namecefixime
INGREDIENTS (9)
CEFIXIMEActive
Quantity: 200 mg in 1 1
Code: 97I1C92E55
Classification: ACTIM
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
cefixime
PRODUCT DETAILS
NDC Product Code27437-206
Application NumberANDA065355
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Namecefixime
INGREDIENTS (6)
CEFIXIMEActive
Quantity: 200 mg in 5 mL
Code: 97I1C92E55
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
cefixime
PRODUCT DETAILS
NDC Product Code27437-201
Application NumberANDA065130
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Namecefixime
INGREDIENTS (10)
CEFIXIMEActive
Quantity: 400 mg in 1 1
Code: 97I1C92E55
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
cefixime
PRODUCT DETAILS
NDC Product Code27437-207
Application NumberNDA202091
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Namecefixime
INGREDIENTS (7)
CEFIXIMEActive
Quantity: 500 mg in 5 mL
Code: 97I1C92E55
Classification: ACTIM
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
cefixime
PRODUCT DETAILS
NDC Product Code27437-208
Application NumberNDA203195
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Namecefixime
INGREDIENTS (14)
CEFIXIMEActive
Quantity: 400 mg in 1 1
Code: 97I1C92E55
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT