Details of the Drug Formulations

General Information of Drug (ID: DM2HRKE)

• Drug Name: Pentosan Polysulfate Drug Info
• Synonyms: Elmiron; Pentosan sulfuric polyester; Polypentose sulfate; Elmiron (TN); Xylan,hydrogen sulfate; [(2R,3R,4S,5R)-2-hydroxy-5-[(2S,3R,4S,5R)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] hydrogen sulfate

Indication

Disease Entry	ICD 11	Status	REF
Interstitial cystitis	GC00.3	Approved	[1]
Painful bladder syndrome	MG30.50	Approved	[1]

• Therapeutic Class: Anticoagulants
• Cross-matching ID:
  PubChem CID: 37720
  CAS Number: 37300-21-3
  TTD ID: D0F8CM
  ACDINA ID: D00516

Full List of Drug Formulations Containing This Drug

Pentosan polysulfate 100 mg capsule

Company	Formulation ID	FDA Description
Physicians Total Care	F16785	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; Titanium dioxide; Aluminum oxide; Cellulose, microcrystalline
Cardinal Health; Janssen Pharmaceutical	F16786	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; Titanium dioxide; Aluminum oxide; Microcrystalline cellulose

Pentosan Polysulfate Sodium 100mg capsule

Company	Formulation ID	FDA Description
Janssen Pharmaceuticals	F23362	Microcrystalline Cellulose; Magnesium Stearate; Gelatin; Pharmaceutical Glaze (Modified) In Sd-45; Synthetic Black Iron Oxide; Fd&C Blue No. 2 Aluminum Lake; Fd&C Red No. 40 Aluminum Lake; Fd&C Blue No. 1 Aluminum Lake; D&C Yellow No. 10 Aluminum Lake; N-Butyl Alcohol; Propylene Glycol; Sda-3A Alcohol; Titanium Dioxide

References

• [1] FDA Approved Drug Products from FDA Official Website. 2009. Application Number: (NDA) 020193.