lansoprazole
These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
da982c79-4f29-467c-b237-1f13c2051c59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-543
Application NumberANDA202366
Product Classification
M
Marketing Category
C73584
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (25)
LANSOPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
lansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-544
Application NumberANDA202366
Product Classification
M
Marketing Category
C73584
G
Generic Name
lansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (25)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LANSOPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 0K5C5T2QPG
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT