eltrombopag olamine

Generic: eltrombopag olamine

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eltrombopag olamine
Generic Name eltrombopag olamine
Labeler somerset therapeutics, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eltrombopag olamine 12.5 mg/1

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-837
Product ID 70069-837_ec6939e2-4f64-4edd-848c-83e73ffac433
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219638
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 70069837
Hyphenated Format 70069-837

Supplemental Identifiers

RxCUI
825421 825427 884617 1245001
UPC
0370069838013 0370069840016 0370069839010 0370069837016
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 olamine (source: ndc)
Generic Name eltrombopag olamine (source: ndc)
Application Number ANDA219638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70069-837-01)
source: ndc

Packages (1)

70069-837-01 30 TABLET, FILM COATED in 1 BOTTLE (70069-837-01)

Ingredients (1)

eltrombopag olamine (12.5 mg/1)

Linked Drug Pages (1)

Eltrombopag olamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ec6939e2-4f64-4edd-848c-83e73ffac433", "openfda": {"upc": ["0370069838013", "0370069840016", "0370069839010", "0370069837016"], "unii": ["4U07F515LG"], "rxcui": ["825421", "825427", "884617", "1245001"], "spl_set_id": ["604f663c-4933-402a-8105-5921713cf3c8"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70069-837-01)", "package_ndc": "70069-837-01", "marketing_start_date": "20260114"}], "brand_name": "Eltrombopag olamine", "product_id": "70069-837_ec6939e2-4f64-4edd-848c-83e73ffac433", "dosage_form": "TABLET, FILM COATED", "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": "70069-837", "generic_name": "Eltrombopag olamine", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eltrombopag olamine", "active_ingredients": [{"name": "ELTROMBOPAG OLAMINE", "strength": "12.5 mg/1"}], "application_number": "ANDA219638", "marketing_category": "ANDA", "marketing_start_date": "20260114", "listing_expiration_date": "20271231"}