Prescription drug · ANDA
Eltrombopag (Eltrombopag olamine) NDC 0054-0965
Eltrombopag olamine 75 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0965-13 | 0005409651300054096513 | 30 TABLET in 1 BOTTLE (0054-0965-13)Marketed from Apr 24, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- eltrombopag olamine
- Active ingredients
- Eltrombopag olamine — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220033
- 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 0054-0965_ad54ce7f-4714-48d1-b511-6be0b11838f9SPL ID ad54ce7f-4714-48d1-b511-6be0b11838f9
- 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
N400054096513followed by a unit qualifier and the quantityPackage 00054-0965-13. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0054-0965
- What is NDC 0054-0965?
- 0054-0965 is the product NDC for Eltrombopag (eltrombopag olamine), Eltrombopag olamine 75 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eltrombopag (Eltrombopag Olamine).
- What is the active ingredient?
- Eltrombopag olamine.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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?
- 37 other product NDCs are listed under this name. See all Eltrombopag NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eltrombopag 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 | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2600 | 00480-2600-56 |
| Eltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-4015 | 00480-4015-56 |
| Eltrombopag | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-4031 | 00480-4031-56 |
| Eltrombopag | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-4210 | 00480-4210-56 |
| Eltrombopag | Eltrombopag olamine 12.5 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-183 | 70377-0183-11 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-184 | 70377-0184-1170377-0184-12 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 50 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-185 | 70377-0185-1170377-0185-1270377-0185-13 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-186 | 70377-0186-1170377-0186-12 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 12.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0962 | 00054-0962-13 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 25 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0963 | 00054-0963-13 |
Other NDCs under ANDA 220033
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 |
|---|---|---|---|---|
| Eltrombopageltrombopag olamine | Eltrombopag olamine 12.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0962 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 25 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0963 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 50 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0964 |