Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
LUPIN LIMITED
675923163
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LUPIN LIMITED
Lupin Pharmaceuticals, Inc.
LUPIN LIMITED
725504448
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CEFIXIME
Product Details
NDC Product Code
68180-407Application Number
ANDA065355Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
CefiximeActive
Code: 97I1C92E55Class: ACTIMQuantity: 200 mg in 5 mL
SUCROSEInactive
Code: C151H8M554Class: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81VClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
CEFIXIME
Product Details
NDC Product Code
68180-416Application Number
ANDA065129Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
CefiximeActive
Code: 97I1C92E55Class: ACTIMQuantity: 400 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CEFIXIME
Product Details
NDC Product Code
68180-423Application Number
NDA203195Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
January 10, 2023CefiximeActive
Code: 97I1C92E55Class: ACTIMQuantity: 400 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CEFIXIME
Product Details
NDC Product Code
68180-405Application Number
ANDA065129Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023CefiximeActive
Code: 97I1C92E55Class: ACTIMQuantity: 100 mg in 5 mL
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81VClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT