Details of the Drug Formulations

General Information of Drug (ID: DMI6HUW)

• Drug Name: Terbinafine Drug Info
• Synonyms: Bramazil; Lamasil; TerbiFoam; Terbina; Lamisil AT; Lamisil Tablet; Ternbinafine HCl; Lamasil (TN); Lamisil (TN); SF 86-327; Terbisil (TN); Zabel (TN); SF-86-327; Terbinafine (USAN/INN); Terbinafine [USAN:BAN:INN]; Lamisil, Terbinex, Corbinal, Zabel, Terbinafine; Terbinafine, SF-86-327, Lamisil, TBNF; (2E)-N,6,6-trimethyl-N-(1-naphthylmethyl)-2-hepten-4-yn-1-amine; (2E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine; (E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine; (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalene methanamine; (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine; (E)-N-(6,6-dimethyl-2-heptenynyl)-N-methyl-1-naphthalenementhamin hydrochloride

Indication

Disease Entry	ICD 11	Status	REF
Fungal infection	1F29-1F2F	Approved	[1]
Tinea corporis	1F28.Y	Approved	[2]
Tinea cruris	1F28.3	Approved	[2]
Tinea versicolor	1F2D.0	Approved	[2]
Onychomycosis	EE12.1	Phase 2	[3]
Tinea pedis	1F28.2	Investigative	[2]

• Therapeutic Class: Antifungal Agents
• Cross-matching ID:
  PubChem CID: 1549008
  ChEBI ID: CHEBI:9448
  CAS Number: 91161-71-6
  TTD ID: D01AYJ
  INTEDE ID: DR1557
  ACDINA ID: D00663

Full List of Drug Formulations Containing This Drug

Terbinafine 250 mg tablet

Company	Formulation ID	FDA Description
Dr Reddy's Laboratories	F20977	Magnesium stearate; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
Physicians Total Care	F20978	Magnesium stearate; Croscarmellose sodium; Silicon dioxide; Methylcellulose (100 cps)
Glenmark Generics	F20979	Magnesium stearate; Crospovidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
Lake Eire Medical & Surgical Supply DBA Quality Care Products	F20983	Magnesium stearate; Hypromellose; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
NorthStar Rx	F20972	Magnesium stearate; Ferric oxide red; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (5 mpa.s); Sodium starch glycolate type a potato
Wockhardt	F20970	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (6 mpa.s); Sodium starch glycolate type a potato
Wockhardt	F20971	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (6 mpa.s); Sodium starch glycolate type a potato
Lake Eire Medical & Surgical Supply DBA Quality Care Products	F20973	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (5 mpa.s); Sodium starch glycolate type a potato
Rebel Distributors	F20974	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium starch glycolate type a potato
Teva Pharmaceuticals	F20975	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (5 mpa.s); Sodium starch glycolate type a potato
Aurobindo Pharma	F20976	Magnesium stearate; Silicon dioxide; Hypromellose 2910 (5 mpa.s); Microcrystalline cellulose; Sodium starch glycolate type a potato
DirectRX; PD-Rx Pharmaceuticals	F20980	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (3 mpa.s); Sodium starch glycolate type a potato
Harris Pharmaceutical; NuCare Pharmaceuticals; Proficient Rx	F20981	Magnesium stearate; Silicon dioxide; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (3 mpa.s); Microcrystalline cellulose; Sodium starch glycolate type a potato
Innocutis	F20982	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium glycolate
Bryant Ranch Prepack	F20984	Magnesium stearate; Silicon dioxide; Hypromellose, unspecified; Microcrystalline cellulose; Sodium starch glycolate type a potato
American Health Packaging; AvKARE; Bryant Ranch Prepack; Camber Pharmaceuticals; Carilion Materials Management; Cipla; Exelan Pharmaceuticals; Harris Pharmaceutical; Novartis Pharmaceuticals Corporation; PD-Rx Pharmaceuticals; Preferred Pharamaceuticals; Proficient Rx; RemedyRepack	F20985	Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium starch glycolate type a potato

Terbinafine Hydrochloride eq 250mg base tablet

Company	Formulation ID	FDA Description
Cipla Usa ; Directrx; Preferred Pharmaceuticals	F24249	Colloidal Silicon Dioxide; Hypromellose; Magnesium Stearate; Microcrystalline Cellulose; Sodium Starch Glycolate

References

• [1] Safety and tolerability of oral antifungal agents in the treatment of fungal nail disease: a proven reality. Ther Clin Risk Manag. 2005 Dec;1(4):299-306.
• [2] Terbinafine FDA Label
• [3] Clinical pipeline report, company report or official report of the Pharmaceutical Research and Manufacturers of America (PhRMA)