Prescription drug · ANDA
Eltrombopag (Eltrombopag olamine) NDC 31722-300
Eltrombopag olamine 12.5 mg/1 · Powder, For suspension · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-300-32 | 31722030032 | 1 CARTON in 1 KIT (31722-300-32) / 30 PACKET in 1 CARTON (31722-300-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-300-12)Marketed from May 13, 2025 |
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
- Generic name (nonproprietary)
- eltrombopag olamine
- Active ingredients
- Eltrombopag olamine — 12.5 mg/1
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216620
- 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 31722-300_315730ec-c40c-af1a-e063-6294a90a010fSPL ID 315730ec-c40c-af1a-e063-6294a90a010fSPL set ID 8f6499f0-4774-4f1e-8ab5-145c1fe64401RxCUI 1859498, 2058980UNII 4U07F515LGUPC 0331722301251, 0331722300124
- 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
N431722030032followed by a unit qualifier and the quantityPackage 31722-0300-32. 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 for oral suspension 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 for oral suspension 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 for oral suspension should be used only in patients with…
Excerpt only. Read the full label for complete information.
About NDC 31722-300
- What is NDC 31722-300?
- 31722-300 is the product NDC for Eltrombopag (eltrombopag olamine), Eltrombopag olamine 12.5 mg/1 powder, for suspension, listed with the FDA by Camber Pharmaceuticals, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 216620
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 25 mg/1 | Powder, For suspensionOral | Camber Pharmaceuticals, Inc. | 31722-301 |