Quick answers
- What is Promacta?
- Promacta is a brand name of Eltrombopag, a prescription medicine. The FDA NDC Directory lists 6 Promacta products in 6 strengths and forms.
- Who makes Promacta?
- Novartis holds the FDA application for Promacta (NDA022291, approved November 20, 2008).
- Is there a generic or store brand of Promacta?
- Yes. The FDA NDC Directory lists 50 other products with the same active ingredients, strength and form as a Promacta product, 50 of them generic. Ask your pharmacist whether one is right for you.
- Has Promacta been recalled?
- FDA enforcement reports list 1 recall of Promacta products; the newest started May 11, 2019. A recall usually concerns specific lots, not every product.
What Promacta is
Each Promacta product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Eltrombopag · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| eltrombopag olamine 12.5 mg powder, for suspension (oral) | Promacta | 1 product, 1 company | DailyMed |
| eltrombopag olamine 12.5 mg tablet, film coated (oral) | Promacta | 12 products, 11 companies | DailyMed |
| eltrombopag olamine 25 mg powder, for suspension (oral) | Promacta | 1 product, 1 company | DailyMed |
| eltrombopag olamine 25 mg tablet, film coated (oral) | Promacta | 12 products, 11 companies | DailyMed |
| eltrombopag olamine 50 mg tablet, film coated (oral) | Promacta | 12 products, 11 companies | DailyMed |
| eltrombopag olamine 75 mg tablet, film coated (oral) | Promacta | 12 products, 11 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Eltrombopag →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Promacta
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Promacta products.
- Novartis Pharmaceuticals Corporation6 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 11, 2019 · Class I · Terminated · D-1309-2019
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ir — Novartis Pharmaceuticals Corp.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.