Quick answers
- What is Eltrombopag used for?
- The FDA-approved label (Promacta, Novartis Pharmaceuticals Corporation, December 18, 2025) says: “PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eltrombopag have a boxed warning?
- Yes. The FDA label for Promacta has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Eltrombopag?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eltrombopag been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 11, 2019 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Eltrombopag?
- 15 companies list prescription products of Eltrombopag in the FDA NDC Directory, including Amneal Pharmaceuticals NY LLC, Novartis Pharmaceuticals Corporation and Camber Pharmaceuticals, Inc..
What Eltrombopag is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. …
— FDA label: Promacta, Novartis Pharmaceuticals Corporation, effective December 18, 2025. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
13 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Powder, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 68 in the FDA NDC Directory |
| Brand names | Promacta |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| eltrombopag olamine 50 mg tablet | Generic | $25.85 per tablet |
| eltrombopag olamine 50 mg tablet, film coated | Generic | $25.85 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals NY LLC8 products
- Novartis Pharmaceuticals Corporation6 products
- Camber Pharmaceuticals, Inc.6 products
- Teva Pharmaceuticals, Inc.4 products
- Dr. Reddy's Laboratories Inc.4 products
- Quallent Pharmaceuticals Health LLC4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Novadoz Pharmaceuticals LLC4 products
- XLCare Pharmaceuticals, Inc.4 products
- Somerset Therapeutics, LLC4 products
- Biocon Pharma Inc.4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Zydus Lifesciences Limited4 products
- Amerisyn LLC4 products
- AvKARE4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022291 PROMACTA | Novartis | November 20, 2008 | 25, latest June 6, 2025 2025: Labeling · 2024: Manufacturing (CMC) · 2023: Manufacturing (CMC) |
| NDA207027 PROMACTA KIT | Novartis | August 24, 2015 | 13, latest June 6, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (11)
- ANDA216620Annora Pharma · April 18, 2024
- ANDA206788Hetero Labs Ltd V · January 17, 2025
- ANDA212884Amneal · January 14, 2026
- ANDA216281Zydus Pharms · January 14, 2026
- ANDA219638Somerset Theraps LLC · January 14, 2026
- ANDA220250Msn · January 14, 2026
- ANDA219121DR Reddys · March 16, 2026
- ANDA220033Hikma · April 8, 2026
- ANDA220660Biocon Pharma · April 28, 2026
- ANDA208815Actavis Labs Fl · June 17, 2026
- ANDA209938Teva Pharms USA · July 13, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Promacta, Novartis Pharmaceuticals Corporation, effective December 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →