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
8dca4887-c75a-4021-8564-b704e9e1fa3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 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 Code24979-001
Application NumberANDA202666
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexlansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2022
FDA Product Classification
INGREDIENTS (20)
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
dexlansoprazoleActive
Quantity: 30 mg in 1 1
Code: UYE4T5I70X
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
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 Code24979-002
Application NumberANDA202666
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexlansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2022
FDA Product Classification
INGREDIENTS (20)
SucroseInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
dexlansoprazoleActive
Quantity: 60 mg in 1 1
Code: UYE4T5I70X
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
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-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT