Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Apace Packaging LLC
TWI PHARMACEUTICALS, INC.
361961142
TWi Pharmaceuticals, Inc. Zhongli Plant
TWI PHARMACEUTICALS, INC.
658863394
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
24979-001Application Number
ANDA202666Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 19, 2022MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
DexlansoprazoleActive
Code: UYE4T5I70XClass: ACTIBQuantity: 30 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Dexlansoprazole delayed release
Product Details
NDC Product Code
24979-002Application Number
ANDA202666Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 19, 2022SucroseInactive
Code: C151H8M554Class: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
DexlansoprazoleActive
Code: UYE4T5I70XClass: ACTIBQuantity: 60 mg in 1 1
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13Class: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive
Code: 5KY68S2577Class: IACT
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT