Eltrombopag
- Product NDC
- 0054-0964
- 11-digit product format
- 000540964
- Labeler code
- 0054
- Product ID
- 0054-0964_64b1a316-d824-44b2-a0c6-785001e11c82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eltrombopag Olamine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA220033
- Marketing category
- ANDA
- Marketing start
- 2026-04-24
- Substance
- ELTROMBOPAG OLAMINE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eltrombopag
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELTROMBOPAG OLAMINE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4U07F515LG |
| Rxcui | 825421, 825427, 884617, 1245001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0964-13 | Eltrombopag | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0964-13 | 00054096413 | 30 TABLET in 1 BOTTLE (0054-0964-13) | 30 tablet | 2026-04-24 | No | No | Historical |