Active ingredient
Palbociclib
9 finished FDA listings contain Palbociclib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PALBOCICLIB
- Dosage forms
- Capsule, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 100 mg/1 · 125 mg/1 · 75 mg/1
- Brand names in FDA listings
- Ibrance
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1601374
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 207103 | PFIZER | 2015-02-03 | 3 |
| NDA 212436 | PFIZER | 2019-11-01 | 6 |
Official labeling on DailyMed
- IBRANCE (PALBOCICLIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] · version 11 · 2026-07-09
- IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] · version 24 · 2026-07-06
- IBRANCE (PALBOCICLIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] · version 13 · 2026-07-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.