Prescription drug · ANDA
Eltrombopag Olamine (eltrombopag) NDC 69238-1414
Eltrombopag olamine 75 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1414-3 | 69238141403 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-1414-3)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 — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 69238-1414_8dba449a-e27a-4f76-a831-6774aa89c217SPL ID 8dba449a-e27a-4f76-a831-6774aa89c217SPL set ID c97337c3-d758-40a3-a1ef-fd122f15e821RxCUI 825421, 825427, 884617, 1245001UNII 4U07F515LGUPC 0369238141634, 0369238141733, 0369238141535, 0369238141436
- 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
N469238141403followed by a unit qualifier and the quantityPackage 69238-1414-03. 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.
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 25 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1416 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1415 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-1417 |
| Eltrombopag Olamineeltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 60219-1417 |
| 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 |
- openFDA data updated
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