Manufacturing Establishments8
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Abbvie Inc
TWI PHARMACEUTICALS, INC.
078458370
Anderson Brecon Inc
TWI PHARMACEUTICALS, INC.
053217022
Catalent Pharma Solutions, LLC
TWI PHARMACEUTICALS, INC.
014167995
Takeda GmbH
TWI PHARMACEUTICALS, INC.
313270015
Takeda Ireland Limited
TWI PHARMACEUTICALS, INC.
988980314
Patheon Manufacturing Services LLC
TWI PHARMACEUTICALS, INC.
079415560
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
TWI PHARMACEUTICALS, INC.
431189117
Takeda Pharmaceutical Company Limited
TWI PHARMACEUTICALS, INC.
695132431
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexlansoprazole delayed release
Product Details
NDC Product Code
24979-704Application Number
NDA022287Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
July 31, 2023DexlansoprazoleActive
Code: UYE4T5I70XClass: ACTIBQuantity: 60 mg in 1 1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
magnesium carbonateInactive
Code: 0E53J927NAClass: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3BClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
carrageenanInactive
Code: 5C69YCD2YJClass: IACT
potassium chlorideInactive
Code: 660YQ98I10Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQKClass: IACT
Dexlansoprazole delayed release
Product Details
NDC Product Code
24979-703Application Number
NDA022287Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
July 31, 2023DexlansoprazoleActive
Code: UYE4T5I70XClass: ACTIBQuantity: 30 mg in 1 1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577Class: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
sucroseInactive
Code: C151H8M554Class: IACT
magnesium carbonateInactive
Code: 0E53J927NAClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3BClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
carrageenanInactive
Code: 5C69YCD2YJClass: IACT
potassium chlorideInactive
Code: 660YQ98I10Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQKClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT