Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
918596198
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lansoprazole
Product Details
NDC Product Code
68382-543Application Number
ANDA202366Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2022LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 15 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
lansoprazole
Product Details
NDC Product Code
68382-544Application Number
ANDA202366Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 10, 2022TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 30 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT