Prescription drug · ANDA
Eltrombopag olamine NDC 87564-032
Eltrombopag olamine 12.5 mg/1 · Tablet, Film coated · Oral · Amerisyn, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87564-032-30 | 87564003230 | 30 TABLET, FILM COATED in 1 BOTTLE (87564-032-30)Marketed from Jun 30, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eltrombopag olamine
- Generic name (nonproprietary)
- eltrombopag olamine
- Active ingredients
- Eltrombopag olamine — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amerisyn, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219638
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Increased Megakaryocyte Maturation (Physiologic effect)Increased Platelet Production (Physiologic effect)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Thrombopoietin Receptor Agonists (Mechanism)UGT1A1 Inhibitors (Mechanism)UGT1A3 Inhibitors (Mechanism)UGT1A4 Inhibitors (Mechanism)UGT1A6 Inhibitors (Mechanism)UGT1A9 Inhibitors (Mechanism)UGT2B15 Inhibitors (Mechanism)UGT2B7 Inhibitors (Mechanism)
- Identifiers
- Product ID 87564-032_5579564f-8f5f-9071-e063-6294a90a777eSPL ID 5579564f-8f5f-9071-e063-6294a90a777eSPL set ID 52ba8e06-aa7d-caa6-e063-6294a90a5ce5RxCUI 825421, 825427, 884617, 1245001UNII 4U07F515LG
- Pharmacologic class
- Thrombopoietin Receptor Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N487564003230followed by a unit qualifier and the quantityPackage 87564-0032-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Eltrombopag tablets are 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. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thromb…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219638
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Eltrombopag olamine | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-033 |
| Eltrombopag olamine | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-034 |
| Eltrombopag olamine | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-035 |
| Eltrombopag olamine | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Somerset Therapeutics, LLC | 70069-837 |
| Eltrombopag olamine | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Somerset Therapeutics, LLC | 70069-838 |
| Eltrombopag olamine | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Somerset Therapeutics, LLC | 70069-839 |
| Eltrombopag olamine | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Somerset Therapeutics, LLC | 70069-840 |