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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27437-203
Application NumberANDA065380
Product Classification
M
Marketing Category
C73584
G
Generic Name
cefixime
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27437-205
Application NumberANDA065380
Product Classification
M
Marketing Category
C73584
G
Generic Name
cefixime
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27437-206
Application NumberANDA065355
Product Classification
M
Marketing Category
C73584
G
Generic Name
cefixime
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27437-201
Application NumberANDA065130
Product Classification
M
Marketing Category
C73584
G
Generic Name
cefixime
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27437-207
Application NumberNDA202091
Product Classification
M
Marketing Category
C73594
G
Generic Name
cefixime
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27437-208
Application NumberNDA203195
Product Classification
M
Marketing Category
C73594
G
Generic Name
cefixime
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
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