Active ingredient
Methylnaltrexone
3 finished FDA listings contain Methylnaltrexone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHYLNALTREXONE BROMIDE
- Dosage forms
- Injection, Solution, Tablet
- Routes
- Oral, Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 12 mg/.6ml · 150 mg/1 · 8 mg/.4ml
- Brand names in FDA listings
- Relistor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 29899
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021964 | SALIX PHARMS | 2008-04-24 | 2 |
| NDA 208271 | SALIX | 2016-07-19 | 1 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.