Details of the Drug Formulations

General Information of Drug (ID: DML8KTN)

• Drug Name: Danazol Drug Info
• Synonyms: Anatrol; Chronogyn; Cyclomen; Danatrol; Danazant; Danazole; Danazolum; Danocrine; Danogen; Danokrin; Danol; Danoval; Danzol; Ladogal; Norciden; Panacrine; Winobanin; Alphapharm Brand of Danazol; Antigen Brand of Danazol; Kendrick Brand of Danazol; Ratiopharm Brand of Danazol; Sanofi Brand of Danazol; Sanofi Synthelabo Brand ofDanazol; Sanofi Winthrop Brand of Danazol; WIN 17757; Danazol-ratiopharm; Danazolum [INN-Latin]; Danocrine (TN); WIN 17,757; WIN-17757; Win 17, 757; Danazol (JAN/USP/INN); Danazol [USAN:BAN:INN:JAN];[1,2]oxazolo[4',5':2,3]-17alpha-pregn-4-en-20-yn-17-ol; (1R,3aS,3bR,10aR,10bS,12aS)-1-ethynyl-10a,12a-dimethyl-2,3,3a,3b,4,5,10,10a,10b,11,12,12a-dodecahydro-1H-cyclopenta[7,8]phenanthro[3,2-d]isoxazol-1-ol; (1S,2R,13R,14S,17R,18S)-17-ethynyl-2,18-dimethyl-7-oxa-6-azapentacyclo[11.7.0.0^{2,10}.0^{4,8}.0^{14,18}]icosa-4(8),5,9-trien-17-ol; 1-Ethynyl-10a,12a-dimethyl-2,3,3a,3b,4,5,10,10a,10b,11,12,12a-dodecahydro-1H-cyclopenta[7,8]phenanthro[3,2-d]isoxazol-1-ol; 17-alpha-2,4-Pregnadien-20-yno(2,3-d)isoxazol-17-ol; 17-alpha-Pregn-4-en-20-yno(2,3-d)isoxazol-17-ol; 17-alpha-Pregna-2,4-dien-20-yno(2,3-d)isoxazol-17-ol; 17.Alpha.-Pregna-2, {4-dien-20-yno[2,3-d]isoxazol-17-ol}; 17alpha-Pregna-2,4-dien-20-yno(2,3-d)isoxazol-17-ol

Indication

Disease Entry	ICD 11	Status	REF
Menorrhagia	GA20.50	Approved	[1]
Breast cancer	2C60-2C65	Phase 2	[1]
Breast fibrocystic disease		Investigative	[2]
Endometriosis	GA10	Investigative	[2]

• Therapeutic Class: Fertility Agents
• Cross-matching ID:
  PubChem CID: 28417
  ChEBI ID: CHEBI:4315
  CAS Number: 17230-88-5
  TTD ID: D09IPV
  INTEDE ID: DR2401
  ACDINA ID: D00165

Full List of Drug Formulations Containing This Drug

Danazol 100 mg capsule

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F05208	Stearic acid; Lactose monohydrate; 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; Indigotindisulfonate sodium; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Gelatin; Shellac; Sodium starch glycolate type a potato
AvKARE; Lannett Company	F05207	Anhydrous lactose; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Titanium dioxide; Alcohol; Aluminum oxide; Gelatin; Methyl alcohol; Shellac; Starch, corn

Danazol 200 mg capsule

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F05212	Stearic acid; D&c red no. 28; Lactose monohydrate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Indigotindisulfonate sodium; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Gelatin; Shellac; Sodium starch glycolate type a potato
American Health Packaging	F05209	Anhydrous lactose; D&c red no. 28; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Titanium dioxide; 2-ethylaminoethanol; Aluminum oxide; Gelatin; Methyl alcohol; Shellac; Starch, corn
AvKARE; Carilion Materials Management; Lannett Company	F05210	Anhydrous lactose; D&c red no. 28; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Titanium dioxide; Alcohol; Aluminum oxide; Gelatin; Methyl alcohol; Shellac; Starch, corn
AvKARE	F05211	Stearic acid; D&c red no. 28; Lactose monohydrate; 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; Aluminum oxide; Gelatin; Shellac; Sodium starch glycolate type a potato

Danazol 50 mg capsule

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F05214	Stearic acid; Lactose monohydrate; 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; Indigotindisulfonate sodium; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Gelatin; Shellac; Sodium starch glycolate type a potato
AvKARE; Lannett Company	F05213	Anhydrous lactose; Lactose monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Titanium dioxide; Alcohol; Aluminum oxide; Gelatin; Methyl alcohol; Shellac; Starch, corn

References

• [1] 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: 6942).
• [2] Danazol FDA Label