Active ingredient
Upadacitinib
4 finished FDA listings contain Upadacitinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- UPADACITINIB
- Dosage forms
- Solution, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 1 mg/ml · 15 mg/1 · 30 mg/1 · 45 mg/1
- Brand names in FDA listings
- Rinvoq
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2196092
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 211675 | ABBVIE | 2019-08-16 | 3 |
| NDA 218347 | ABBVIE | 2024-04-26 | 1 |
Official labeling on DailyMed
- RINVOQ (UPADACITINIB) TABLET, EXTENDED RELEASE RINVOQ (UPADACITINIB) SOLUTION [ABBVIE INC.] · version 101 · 2026-07-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.