eltrombopag

Generic: eltrombopag

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eltrombopag
Generic Name eltrombopag
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eltrombopag olamine 50 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1397
Product ID 70710-1397_8f8b3109-d174-4138-b14f-f956a4578ca9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216281
Listing Expiration 2027-12-31
Marketing Start 2026-01-14

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101397
Hyphenated Format 70710-1397

Supplemental Identifiers

RxCUI
825421 825427 884617 1245001
UPC
0370710139636 0370710139735
UNII
4U07F515LG

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name eltrombopag (source: ndc)
Generic Name eltrombopag (source: ndc)
Application Number ANDA216281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70710-1397-3)
  • 14 TABLET in 1 BOTTLE (70710-1397-7)
source: ndc

Packages (2)

70710-1397-3 30 TABLET in 1 BOTTLE (70710-1397-3) 70710-1397-7 14 TABLET in 1 BOTTLE (70710-1397-7)

Ingredients (1)

eltrombopag olamine (50 mg/1)

Linked Drug Pages (1)

ELTROMBOPAG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f8b3109-d174-4138-b14f-f956a4578ca9", "openfda": {"upc": ["0370710139636", "0370710139735"], "unii": ["4U07F515LG"], "rxcui": ["825421", "825427", "884617", "1245001"], "spl_set_id": ["1cfdd1fa-d687-41f9-a160-9491f0beac1e"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70710-1397-3)", "package_ndc": "70710-1397-3", "marketing_start_date": "20260114"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (70710-1397-7)", "package_ndc": "70710-1397-7", "marketing_start_date": "20260114"}], "brand_name": "ELTROMBOPAG", "product_id": "70710-1397_8f8b3109-d174-4138-b14f-f956a4578ca9", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "70710-1397", "generic_name": "eltrombopag", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELTROMBOPAG", "active_ingredients": [{"name": "ELTROMBOPAG OLAMINE", "strength": "50 mg/1"}], "application_number": "ANDA216281", "marketing_category": "ANDA", "marketing_start_date": "20260114", "listing_expiration_date": "20271231"}