Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
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
60687-123Application Number
ANDA091269Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 17, 2023AMMONIAInactive
Code: 5138Q19F1XClass: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
RAW SUGARInactive
Code: 8M707QY5GHClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 30 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Lansoprazole
Product Details
NDC Product Code
60687-111Application Number
ANDA091269Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 17, 2023SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
RAW SUGARInactive
Code: 8M707QY5GHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 15 mg in 1 1
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT