Active ingredient
Naloxegol
3 finished FDA listings contain Naloxegol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NALOXEGOL OXALATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 12.5 mg/1 · 25 mg/1
- Brand names in FDA listings
- Movantik
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1551777
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 204760 | AVERITAS | 2014-09-16 | 3 |
Official labeling on DailyMed
- MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [AVERITAS PHARMA, INC.] · version 5 · 2026-09-02
- MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [REDHILL BIOPHARMA LTD] · version 5 · 2024-12-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.