Dexlansoprazole
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)
Approved
Approval ID
9abcfb1e-c894-44bb-807a-e4bdd755f28f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2023
Manufacturers
FDA
TWI PHARMACEUTICALS, INC.
DUNS: 658402052
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dexlansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-704
Application NumberNDA022287
Product Classification
M
Marketing Category
C73605
G
Generic Name
dexlansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (19)
dexlansoprazoleActive
Quantity: 60 mg in 1 1
Code: UYE4T5I70X
Classification: ACTIB
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
magnesium carbonateInactive
Code: 0E53J927NA
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
carrageenanInactive
Code: 5C69YCD2YJ
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
dexlansoprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-703
Application NumberNDA022287
Product Classification
M
Marketing Category
C73605
G
Generic Name
dexlansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (20)
dexlansoprazoleActive
Quantity: 30 mg in 1 1
Code: UYE4T5I70X
Classification: ACTIB
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
magnesium carbonateInactive
Code: 0E53J927NA
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
carrageenanInactive
Code: 5C69YCD2YJ
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT