Eltrombopag (eltrombopag olamine) NDC 0054-0965

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0965Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0965Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0054-0965-13	00054096513	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220033
Marketing start: Apr 24, 2026
Listing expires: Dec 31, 2027
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

N400054096513 followed by a unit qualifier and the quantity

Package 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.

Other NDCs under ANDA 220033

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 220033
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