Details of the Drug Formulations

General Information of Drug (ID: DM8WAHT)

Drug Name
Fentanyl Drug Info
Synonyms
fentanyl; Fentanil; Phentanyl; Fentora; Sublimaze; Fentanila; Fentanest; Duragesic; Fentanylum; Durogesic; Sentonil; 437-38-7; Duragesic-100; IONSYS; Duragesic-25; Duragesic-75; Duragesic-50; Duragesic-12; Fentanyl-25; Fentanyl-75; Fentanyl-12; Fentanyl-50; Fentanylum [INN-Latin]; Fentanila [INN-Spanish]; Fentanyl-100; 1-Phenethyl-4-N-propionylanilinopiperidine; Matrifen; Sublimase; N-(1-Phenethylpiperidin-4-yl)-N-phenylpropionamide; N-(1-Phenethyl-4-piperidyl)propionanilide; N-Phenethyl-4-(N-propionylanilino)piperidine; Fentanil [DCIT]; Subsys; Fentanyl-37; Fentanyl-62; Fentanyl-87; Abstral; Actiq; Lazanda; Onsolis; Fentanyl Citrate; Fentanyl Citrate Preservative Free; Sublimaze Preservative Free; fentanyl (transmucosal film, pain), Auxilium Pharmaceuticals
Indication
Disease Entry ICD 11 Status REF
Analgesia MB40.8 Approved [1]
Traumatic brain injury NA07.Z Approved [2]
Cancer related pain MG30 Phase 3 [3]
Pain MG30-MG3Z Phase 3 [4]
Chronic pain MG30 Phase 1 [5]
Therapeutic Class
Neurology Agents
Cross-matching ID
PubChem CID
3345
ChEBI ID
CHEBI:119915
CAS Number
437-38-7
TTD ID
D0E1WI
VARIDT ID
DR00430
INTEDE ID
DR0690
ACDINA ID
D00271

Full List of Drug Formulations Containing This Drug

Fentanyl 0.1 mg tablet
Company Formulation ID FDA Description
Cephalon F08097 Anhydrous citric acid; Magnesium stearate; Mannitol; Sodium bicarbonate; Sodium carbonate; Sodium starch glycolate type a potato
ProStrakan F08098 Magnesium stearate; Mannitol; Croscarmellose sodium; Cellulose, microcrystalline
Actavis Pharma F08096 Magnesium stearate; Mannitol; Potassium bicarbonate; Sodium starch glycolate type a potato
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Fentanyl 0.2 mg tablet
Company Formulation ID FDA Description
Cephalon F08100 Anhydrous citric acid; Magnesium stearate; Mannitol; Sodium bicarbonate; Sodium carbonate; Sodium starch glycolate type a potato
ProStrakan F08101 Magnesium stearate; Mannitol; Croscarmellose sodium; Cellulose, microcrystalline
Actavis Pharma F08099 Magnesium stearate; Mannitol; Potassium bicarbonate; Sodium starch glycolate type a potato
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Fentanyl 0.4 mg tablet
Company Formulation ID FDA Description
Cephalon F08104 Anhydrous citric acid; Magnesium stearate; Mannitol; Sodium bicarbonate; Sodium carbonate; Sodium starch glycolate type a potato
ProStrakan F08105 Magnesium stearate; Mannitol; Croscarmellose sodium; Cellulose, microcrystalline
Actavis Pharma F08103 Magnesium stearate; Mannitol; Potassium bicarbonate; Sodium starch glycolate type a potato
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Fentanyl 0.6 mg tablet
Company Formulation ID FDA Description
Cephalon F08107 Anhydrous citric acid; Magnesium stearate; Mannitol; Sodium bicarbonate; Sodium carbonate; Sodium starch glycolate type a potato
ProStrakan F08108 Magnesium stearate; Mannitol; Croscarmellose sodium; Cellulose, microcrystalline
Actavis Pharma F08106 Magnesium stearate; Mannitol; Potassium bicarbonate; Sodium starch glycolate type a potato
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Fentanyl 0.8 mg tablet
Company Formulation ID FDA Description
Cephalon F08110 Anhydrous citric acid; Magnesium stearate; Mannitol; Sodium bicarbonate; Sodium carbonate; Sodium starch glycolate type a potato
ProStrakan F08111 Magnesium stearate; Mannitol; Croscarmellose sodium; Cellulose, microcrystalline
Actavis Pharma F08109 Magnesium stearate; Mannitol; Potassium bicarbonate; Sodium starch glycolate type a potato
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Fentanyl 0.3 mg tablet
Company Formulation ID FDA Description
ProStrakan F08102 Magnesium stearate; Mannitol; Croscarmellose sodium; Cellulose, microcrystalline
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References

1 Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
2 Fentanyl FDA Label
3 ClinicalTrials.gov (NCT00822614) Safety of Fentanyl TAIFUN Treatment. U.S. National Institutes of Health.
4 A Phase III study to assess the clinical utility of low-dose fentanyl transdermal system in patients with chronic nonmalignant pain. Curr Med Res Opin. 2006 Aug;22(8):1493-501.
5 Clinical pipeline report, company report or official report of the Pharmaceutical Research and Manufacturers of America (PhRMA)