Details of the Drug Formulations

General Information of Drug (ID: DM1DBV5)

• Drug Name: Dexlansoprazole Drug Info
• Synonyms: dexlansoprazole; (R)-Lansoprazole; 138530-94-6; Kapidex; dexilant; R-(+)-LANSOPRAZOLE; Dexilant Solutab; TAK 390; UNII-UYE4T5I70X; TAK-390; (r)-(+)-lansoprazole; T 168390; UYE4T5I70X; AK170558; TAK-390MR; T-168390; 2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole; 2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1H-benzimidazole; (R)-2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole; Dexlansoprazole (INN/USAN); Kapidex; KS-1075; Lansoprazole

Indication

Disease Entry	ICD 11	Status	REF
Erosive esophagitis	DA25.0	Approved	[1]
Non-erosive gastro-esophageal reflux disease	DA22.0	Approved	[1]
Peptic ulcer	DA61	Approved	[2]
NSAID-associated gastric ulcer	DA60	Phase 3	[2]

• Cross-matching ID:
  PubChem CID: 9578005
  ChEBI ID: CHEBI:135931
  CAS Number: 138530-94-6
  TTD ID: D06YYD
  VARIDT ID: DR00643
  INTEDE ID: DR0469
  ACDINA ID: D00187

Full List of Drug Formulations Containing This Drug

Dexlansoprazole 30 mg tablet

Company	Formulation ID	FDA Description
Takeda Pharmaceuticals America	F05486	Anhydrous citric acid; Lactose monohydrate; Sucralose; Glyceryl monostearate; Magnesium stearate; Mannitol; Ferric oxide red; Ferric oxide yellow; Magnesium carbonate; Talc; Titanium dioxide; Triethyl citrate; Polysorbate 80; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hydroxypropyl cellulose (type h); Hydroxypropyl cellulose, low substituted; Hypromellose 2910 (6 mpa.s); Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid 7:3:1 280000 mw); Polyethylene glycol 8000

Dexlansoprazole 30 mg capsule

Company	Formulation ID	FDA Description
Physicians Total Care	F05484	Fd&c blue no. 2; Potassium chloride; Ferric oxide red; Magnesium carbonate; Sucrose; Talc; Titanium dioxide; Triethyl citrate; Hypromellose; Polysorbate 80; Silicon dioxide; Aluminum oxide; Carrageenan; Hydroxypropyl cellulose; Hydroxypropyl cellulose, low substituted; Hypromellose 2910 (15 cps); Polyethylene glycol 8000
Takeda Pharmaceuticals America	F05485	Fd&c blue no. 2; Potassium chloride; Ferric oxide red; Magnesium carbonate; Sucrose; Talc; Titanium dioxide; Triethyl citrate; Polysorbate 80; Silicon dioxide; Aluminum oxide; Carrageenan; Hydroxypropyl cellulose (1200000 mw); Hypromellose 2910 (6 mpa.s); Low-substituted hydroxypropyl cellulose, unspecified; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol 8000; Starch, corn

Dexlansoprazole 60 mg capsule

Company	Formulation ID	FDA Description
Cardinal Health	F05487	Fd&c blue no. 2; Potassium chloride; Magnesium carbonate; Sucrose; Talc; Titanium dioxide; Triethyl citrate; Polysorbate 80; Silicon dioxide; Aluminum oxide; Carrageenan; Hydroxypropyl cellulose (1200000 mw); Hypromellose 2910 (6 mpa.s); Low-substituted hydroxypropyl cellulose, unspecified; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol 8000
Physicians Total Care	F05488	Fd&c blue no. 2; Potassium chloride; Magnesium carbonate; Sucrose; Talc; Titanium dioxide; Triethyl citrate; Polysorbate 80; Silicon dioxide; Aluminum oxide; Carrageenan; Hydroxypropyl cellulose; Hydroxypropyl cellulose, low substituted; Hypromelloses; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol 8000
Takeda Pharmaceuticals America	F05489	Fd&c blue no. 2; Potassium chloride; Magnesium carbonate; Sucrose; Talc; Titanium dioxide; Triethyl citrate; Polysorbate 80; Silicon dioxide; Aluminum oxide; Carrageenan; Hydroxypropyl cellulose (1200000 mw); Hypromellose 2910 (6 mpa.s); Low-substituted hydroxypropyl cellulose, unspecified; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol 8000; Starch, corn

References

• [1] FDA Approved Drug Products from FDA Official Website. 2009. Application Number: (NDA) 022287.
• [2] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 7208).