Prescription drug · ANDA
Eltrombopag NDC 70377-183
Eltrombopag olamine 12.5 mg/1 · Tablet, Film coated · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-183-11 | 70377018311 | 30 TABLET, FILM COATED in 1 BOTTLE (70377-183-11)Marketed from Sep 9, 2026 |
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
- Active ingredients
- Eltrombopag olamine — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Biocon Pharma Inc.NDC labeler code 70377
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220660
- 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 70377-183_d3dd9b3b-e4c2-90e7-f22a-53b70f494f65SPL ID d3dd9b3b-e4c2-90e7-f22a-53b70f494f65SPL set ID 074dbfa7-eadb-e722-0a7a-86a97882f031RxCUI 825421, 825427, 884617, 1245001UNII 4U07F515LG
- 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
N470377018311followed by a unit qualifier and the quantityPackage 70377-0183-11. 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 tablets are 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 thro…
Excerpt only. Read the full label for complete information.
About NDC 70377-183
- What is NDC 70377-183?
- 70377-183 is the product NDC for Eltrombopag, Eltrombopag olamine 12.5 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eltrombopag.
- What is the active ingredient?
- Eltrombopag olamine.
- Who is the labeler?
- Biocon Pharma Inc., NDC labeler code 70377. 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 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 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2600 | 00480-2600-56 |
| 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 75 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0965 | 00054-0965-13 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 25 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0963 | 00054-0963-13 |
Other NDCs under ANDA 220660
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 50 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-185 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 25 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-184 |
| Eltrombopageltrombopag olamine | Eltrombopag olamine 75 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-186 |