Details of the Drug Formulations

General Information of Drug (ID: DM7VTQO)

• Drug Name: Entecavir Drug Info
• Synonyms: Baraclude; ETV; Entecavir hydrate; Entecavir monohydrate; BMS-200475; Baraclude (TN); Entecavir (INN); Entecavir (USAN); Entecavir hydrate (JAN); SQ-34676; 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one; 2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1,9-dihydro-6H-purin-6-one; 2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1,9-dihydro-6H-purin-6-one-water (1/1); 2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-3H-purin-6-one; 6-H-Purin-6-one-,2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]; 9-((1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)guanine monohydrate

Indication

Disease Entry	ICD 11	Status	REF
Hepatitis B virus infection	1E51.0	Approved	[1]

• Therapeutic Class: Antiviral Agents
• Cross-matching ID:
  PubChem CID: 135398508
  ChEBI ID: CHEBI:473990
  CAS Number: 142217-69-4
  TTD ID: D0KR2J
  VARIDT ID: DR01277
  ACDINA ID: D00232

Full List of Drug Formulations Containing This Drug

Entecavir 1 mg tablet

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F07310	Fd&c red no. 40; Fd&c blue no. 2; Magnesium stearate; Mannitol; Ferric oxide yellow; Talc; Titanium dioxide; Polyethylene glycol 3350; Polyethylene glycol 4000; Crospovidone, unspecified; Microcrystalline cellulose; Polyvinyl alcohol, unspecified; Starch, corn
Camber Pharmaceuticals	F07307	Calcium carbonate; Sodium stearyl fumarate; Citric acid monohydrate; Ferric oxide red; Titanium dioxide; Carboxymethylcellulose sodium; Hypromelloses; Starch, corn; Thiamine mononitrate
Par Pharmaceutical	F07313	Lactose monohydrate; Fd&c yellow no. 6; Magnesium stearate; Ferric oxide yellow; Talc; Titanium dioxide; Crospovidone (12 mpa.s at 5%); Crospovidone, unspecified; Microcrystalline cellulose; Peg-2 stearate; Polyvinyl alcohol (100000 mw)
Par Pharmaceutical	F07315	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Titanium dioxide; Crospovidone; Polyethylene glycol 400; Cellulose, microcrystalline; Hypromelloses; Povidones
Cadila Healthcare; Zydus Pharmaceuticals	F07308	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Crospovidone; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Amneal Pharmaceuticals; Marlex Pharmaceuticals	F07309	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Titanium dioxide; Povidone; Cellulose, microcrystalline; Crospovidone (12 mpa.s at 5%); Hypromelloses; Polyethylene glycol 8000
Cipla; NorthStar Rx	F07312	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Titanium dioxide; Polyethylene glycol 400; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromellose 2910 (6 mpa.s); Povidones
E.R. Squibb & Sons	F07314	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Titanium dioxide; Polyethylene glycol 400; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromelloses; Povidones
Aurobindo Pharma; Lucid Pharma	F07306	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Crospovidone; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
AvKARE	F07311	Lactose monohydrate; Magnesium stearate; Ferric oxide red; Titanium dioxide; Cellulose, microcrystalline; Crospovidone (12 mpa.s at 5%); Hypromelloses; Polyethylene glycol 8000; Povidones

Entecavir 0.5 mg tablet

Company	Formulation ID	FDA Description
Camber Pharmaceuticals	F07296	Calcium carbonate; Sodium stearyl fumarate; Citric acid monohydrate; Titanium dioxide; Carboxymethylcellulose sodium; Polysorbate 80; Polyethylene glycols; Starch, corn; Thiamine mononitrate
Teva Pharmaceuticals	F07300	Magnesium stearate; Mannitol; Talc; Titanium dioxide; Polyethylene glycol 3350; Crospovidone, unspecified; Microcrystalline cellulose; Polyvinyl alcohol, unspecified; Starch, corn
Par Pharmaceutical	F07305	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Crospovidone; Polyethylene glycol 400; Polysorbate 80; Cellulose, microcrystalline; Hypromelloses; Povidones
E.R. Squibb & Sons	F07304	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Polysorbate 80; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromelloses; Povidones
Cadila Healthcare; Zydus Pharmaceuticals	F07297	Lactose monohydrate; Magnesium stearate; Talc; Titanium dioxide; Crospovidone; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Aurobindo Pharma; Lucid Pharma	F07295	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Crospovidone; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Amneal Pharmaceuticals; Marlex Pharmaceuticals	F07298	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Povidone; Cellulose, microcrystalline; Crospovidone (12 mpa.s at 5%); Hypromelloses; Polyethylene glycol 8000
Cipla; NorthStar Rx	F07302	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polyethylene glycol 6000; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Hypromellose 2910 (15 mpa.s); Povidones
Par Pharmaceutical	F07303	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Polysorbate 80; Crospovidone (12 mpa.s at 5%); Hypromellose, unspecified; Microcrystalline cellulose; Peg-2 stearate; Povidone, unspecified
American Health Packaging	F07299	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Crospovidone (15 mpa.s at 5%); Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified
AvKARE	F07301	Lactose monohydrate; Magnesium stearate; Titanium dioxide; Cellulose, microcrystalline; Crospovidone (12 mpa.s at 5%); Hypromelloses; Polyethylene glycol 8000; Povidones

References

• [1] Natural products as sources of new drugs over the last 25 years. J Nat Prod. 2007 Mar;70(3):461-77.