Active ingredient
Sotorasib
3 finished FDA listings contain Sotorasib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SOTORASIB
- Dosage forms
- Tablet, Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 120 mg/1 · 240 mg/1 · 320 mg/1
- Brand names in FDA listings
- Lumakras
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2550714
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 214665 | AMGEN INC | 2021-05-28 | 3 |
Official labeling on DailyMed
- LUMAKRAS (SOTORASIB) TABLET, COATED [AMGEN INC] · version 19 · 2025-01-30
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.