Details of the Drug Formulations

General Information of Drug (ID: DMCUT21)

• Drug Name: Ursodeoxycholic acid Drug Info
• Synonyms: Actigall; Antigall; Arsacol; Delursan; Destolit; Deursil; Litursol; Lyeton; Peptarom; Solutrat; UDCA; UDCS; UrSO; Urosiol; Ursacol; Ursobilin; Ursochol; Ursodamor; Ursodeoxycholate; Ursodiol; Ursofalk; Ursolvan; Ursosan; Acide ursodesoxycholique; Acido ursodeossicolico; Acido ursodeossicolico [Italian]; Acido ursodeoxicolico; Acidum ursodeoxycholicum; Deoxyursocholic Acid; Sodium Ursodeoxycholate; Ursacholic Acid; Urso DS; Urso Forte; Ursodeoxy cholic acid; Ursodesoxycholicacid; Ursodexycholic Acid; Ursodiol [USAN]; IU5; U0030; Urso 250; Acide ursodesoxycholique [INN-French]; Acido ursodeoxicolico [INN-Spanish]; Acidum ursodeoxycholicum [INN-Latin]; Actigall (TN); Cholit-ursan; Deursil (TN); Dom-ursodiol c; ISO-URSODEOXYCHOLIC ACID; PHL-ursodiol c; PMS-ursodiol c; U-9000; Urso (TN); Urso Forte (TN); Ursodiol (USP); Ursosan (TN); Ursodeoxycholic acid (JP15/INN); Ursodeoxycholic acid, UDCA, Ursosan, Ursofalk, Urso Forte, Udiliv, Ursodiol; Cholan-24-oic acid, 3,7-dihydroxy-, (3-alpha,5-beta,7-beta)-(9CI); (3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid; (3alpha,5beta,7beta,8xi)-3,7-dihydroxycholan-24-oic acid; (4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid; 17-beta-(1-Methyl-3-carboxypropyl)etiocholane-3-alpha,7-beta-diol; 3 alpha,7 beta-Dihydroxy-5 beta-cholan-24-oic Acid; 3,7-Dihydroxycholan-24-oic acid; 3-alpha,7-beta-Dihydroxy-5-beta-cholanoic acid; 3-alpha,7-beta-Dihydroxycholanic acid; 3-alpha,7-beta-Dioxycholanic acid; 3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid; 3alpha,7beta-Dihydroxy-5beta-cholanic acid; 5beta-Cholan-24-oic acid-3alpha,7beta-diol; 5beta-Cholanic Acid-3alpha,7beta-diol; 7-beta-Hydroxylithocholic acid; 7beta-Hydroxylithocholic acid

Indication

Disease Entry	ICD 11	Status	REF
Cholelithiasis	DC11	Approved	[1]
Primary biliary cholangitis	DB96.1	Approved	[2]
Primary biliary cirrhosis	DB96.1	Approved	[3]
Colon cancer	2B90.Z	Investigative	[4]

• Therapeutic Class: Cholagogues and Choleretics
• Cross-matching ID:
  PubChem CID: 31401
  ChEBI ID: CHEBI:9907
  CAS Number: 128-13-2
  TTD ID: D0G3SH
  VARIDT ID: DR00615
  INTEDE ID: DR2172
  ACDINA ID: D00713

Full List of Drug Formulations Containing This Drug

Ursodeoxycholic acid 300 mg capsule

Company	Formulation ID	FDA Description
Golden State Medical Supply; Mylan Pharamceuticals	F21755	Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Fd&c yellow no. 6; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxypropyl cellulose (type h); Shellac; Sodium starch glycolate type a potato; Starch, corn
AvPAK; Lannett Company; Major Pharmaceuticals	F21751	D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Fd&c yellow no. 6; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Alcohol; Aluminum oxide; Gelatin; Methyl alcohol; Shellac; Starch, corn
Marlex Pharmaceuticals	F21761	D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Fd&c yellow no. 6; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Alcohol; Gelatin; Methyl alcohol; Shellac; Starch, corn
American Health Packaging	F21762	D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Fd&c yellow no. 6; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Alcohol; Gelatin, unspecified; Methyl alcohol; Shellac; Starch, corn
AvKARE	F21756	D&c red no. 28; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
Avera McKennan Hospital; Epic Pharma; PuraCap Laboratories	F21757	D&c red no. 28; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
Golden State Medical Supply	F21759	D&c red no. 28; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
TAGI Pharma	F21763	D&c red no. 28; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Aluminum oxide; Gelatin; Starch, corn
AvPAK	F21758	D&c red no. 28; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Titanium dioxide; Silicon dioxide; Gelatin; Starch, corn
Major Pharmaceuticals	F21760	D&c red no. 28; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Starch, corn
A-S Medication Solutions; Actavis Pharma; Carilion Materials Management; Physicians Total Care; Preferred Pharamaceuticals	F21753	Magnesium stearate; Ferric oxide red; Ferrosoferric oxide; Silicon dioxide; Gelatin; Starch, corn
American Health Packaging; Cardinal Health	F21754	Magnesium stearate; Ferrosoferric oxide; Titanium dioxide; Silicon dioxide; Gelatin; Starch, corn
NCS HealthCare of KY, Inc dba Vangard Labs; Stat Rx USA	F21752	Magnesium stearate; Ferrosoferric oxide; Colloidal silicon dioxide; Ferric oxide; Gelatin; Starch, corn

Ursodeoxycholic acid 250 mg tablet

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F21747	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Polyethylene glycol 3350; Polyethylene glycol 6000; Silicon dioxide; Cellulose, microcrystalline; Ethylcellulose (10 mpa.s); Hypromelloses; Povidone k90; Sodium starch glycolate type a potato
Actavis Pharma	F21744	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Hydrogen peroxide; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycol 8000; Povidone k29/32; Sodium starch glycolate type a potato
Cardinal Health	F21750	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Hydrogen peroxide; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromellose 2910 (15000 mpa.s); Polyethylene glycol 8000; Povidones; Sodium starch glycolate type a potato
Glenmark Pharmaceutials	F21745	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycol 8000; Povidones; Sodium starch glycolate type a potato
Impax Generics	F21741	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Povidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium starch glycolate type a potato
Actavis Pharma; BluePoint Laboratories	F21742	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Povidones; Sodium starch glycolate type a potato
Par Pharmaceutical	F21743	Magnesium stearate; Titanium dioxide; Medium-chain triglycerides; Polyethylene glycol 3350; Cellulose, microcrystalline; Copovidone; Hypromelloses; Polydextrose; Povidone k29/32; Sodium starch glycolate type a potato
Avera McKennan Hospital	F21749	Magnesium stearate; Titanium dioxide; Medium-chain triglycerides; Polyethylene glycol 3350; Cellulose, microcrystalline; Copovidone k25-31; Hypromelloses; Polydextrose; Povidone k29/32; Sodium starch glycolate type a potato
American Health Packaging	F21746	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
Allergan	F21748	Dibutyl sebacate; Magnesium stearate; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycol 8000; Povidone k29/32; Sodium starch glycolate type a potato

Ursodeoxycholic acid 500 mg tablet

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F21769	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Polyethylene glycol 3350; Polyethylene glycol 6000; Silicon dioxide; Cellulose, microcrystalline; Ethylcellulose (10 mpa.s); Hypromelloses; Povidone k90; Sodium starch glycolate type a potato
Actavis Pharma	F21767	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Hydrogen peroxide; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycol 8000; Povidone k29/32; Sodium starch glycolate type a potato
Glenmark Pharmaceutials	F21768	Sodium lauryl sulfate; Cetyl alcohol; Dibutyl sebacate; Magnesium stearate; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycol 8000; Povidones; Sodium starch glycolate type a potato
Impax Generics	F21764	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Povidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium starch glycolate type a potato
Actavis Pharma; BluePoint Laboratories; Lake Eire Medical & Surgical Supply DBA Quality Care Products	F21765	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Povidones; Sodium starch glycolate type a potato
Par Pharmaceutical	F21766	Magnesium stearate; Titanium dioxide; Medium-chain triglycerides; Polyethylene glycol 3350; Cellulose, microcrystalline; Copovidone; Hypromelloses; Polydextrose; Povidone k29/32; Sodium starch glycolate type a potato
Allergan	F21770	Dibutyl sebacate; Magnesium stearate; Polyethylene glycol 3350; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromelloses; Polyethylene glycol 8000; Povidone k29/32; Sodium starch glycolate type a potato

References

• [1] Management of symptomatic cholelithiasis: a systematic review. Syst Rev. 2022 Dec 12;11(1):267.
• [2] Primary biliary cholangitis: pathogenesis and therapeutic opportunities. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):93-110.
• [3] 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: 7104).
• [4] Design and synthesis of bile acid derivatives and their activity against colon cancer. RSC Med Chem. 2022 Aug 19;13(11):1391-1409.