Prescription drug · ANDA
Eltrombopag Olamine (Eltrombopag) NDC 60219-1417
Eltrombopag olamine 12.5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1417-3 | 6021914170360219141703 | 30 TABLET, FILM COATED in 1 BOTTLE (60219-1417-3)Marketed from Jan 15, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Eltrombopag olamine — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212884
- 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 60219-1417_992e50d5-b6c2-4213-9c7c-ef25c84d0708SPL ID 992e50d5-b6c2-4213-9c7c-ef25c84d0708SPL set ID 05acf38e-7870-4809-a045-fc38e66b1110RxCUI 825421, 825427, 884617, 1245001UNII 4U07F515LGUPC 0360219141735
- 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
N460219141703followed by a unit qualifier and the quantityPackage 60219-1417-03. 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 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. 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 thrombocyto…
Excerpt only. Read the full label for complete information.
About NDC 60219-1417
- What is NDC 60219-1417?
- 60219-1417 is the product NDC for Eltrombopag Olamine (eltrombopag), Eltrombopag olamine 12.5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eltrombopag Olamine (Eltrombopag).
- What is the active ingredient?
- Eltrombopag olamine.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eltrombopag Olamine?
- 19 other product NDCs are listed under this name. See all Eltrombopag Olamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eltrombopag Olamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eltrombopag olamine | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-032 | 87564-0032-30 |
| Eltrombopag olamine | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-033 | 87564-0033-30 |
| Eltrombopag olamine | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-034 | 87564-0034-30 |
| Eltrombopag olamine | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Amerisyn, LLC | 87564-035 | 87564-0035-30 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-932 | 42291-0932-30 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-933 | 42291-0933-30 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-934 | 42291-0934-30 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-935 | 42291-0935-30 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1414 | 60219-1414-03 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1415 | 60219-1415-03 |
Other NDCs under ANDA 212884
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 Olamineeltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-932 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-933 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-934 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-935 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1414 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1415 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1416 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1414 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1415 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1416 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1417 |