Active ingredient
Alvimopan
4 finished FDA listings contain Alvimopan as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALVIMOPAN
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 12 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 480639
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 |
|---|---|---|---|
| ANDA 208295 | WATSON LABS TEVA | 2019-12-19 | 1 |
| ANDA 216843 | PH HEALTH | 2023-01-24 | 1 |
| ANDA 217753 | HIKMA | 2023-08-31 | 2 |
Official labeling on DailyMed
- ALVIMOPAN CAPSULE [PAR HEALTH USA, LLC] · version 12 · 2026-04-23
- ALVIMOPAN CAPSULE [HIKMA PHARMACEUTICALS USA INC.] · version 2 · 2024-02-07
- ALVIMOPAN CAPSULE [ACTAVIS PHARMA, INC.] · version 5 · 2024-01-25
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.