Active ingredient
Osimertinib
4 finished FDA listings contain Osimertinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- OSIMERTINIB, OSIMERTINIB MESYLATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 40 mg/1 · 80 mg/1
- Brand names in FDA listings
- Tagrisso
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1721560
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 208065 | ASTRAZENECA | 2015-11-13 | 4 |
Official labeling on DailyMed
No DailyMed labels matched by set ID.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.