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
caad4ada-2cf9-4e12-99df-6ca4388cf0f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code72162-2244
Application NumberANDA202294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexlansoprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (22)
DEXLANSOPRAZOLEActive
Quantity: 30 mg in 1 1
Code: UYE4T5I70X
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM HYDROXIDEInactive
Code: PF5DZW74VN
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LAURYL SULFATEInactive
Code: DIQ16UC154
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT