promacta

Generic: eltrombopag olamine

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name promacta
Generic Name eltrombopag olamine
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eltrombopag olamine 12.5 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0684
Product ID 0078-0684_b8a1cc48-9aaf-486a-9305-090acccb5c02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022291
Listing Expiration 2026-12-31
Marketing Start 2016-08-22

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 00780684
Hyphenated Format 0078-0684

Supplemental Identifiers

RxCUI
825421 825425 825427 825429 884617 884619 1245001 1245003 1859498 1859501 2058980 2058981
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 promacta (source: ndc)
Generic Name eltrombopag olamine (source: ndc)
Application Number NDA022291 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15)
source: ndc

Packages (1)

0078-0684-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15)

Ingredients (1)

eltrombopag olamine (12.5 mg/1)

Linked Drug Pages (1)

PROMACTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b8a1cc48-9aaf-486a-9305-090acccb5c02", "openfda": {"unii": ["4U07F515LG"], "rxcui": ["825421", "825425", "825427", "825429", "884617", "884619", "1245001", "1245003", "1859498", "1859501", "2058980", "2058981"], "spl_set_id": ["7714a0ed-34bb-46e6-a0a5-b363908b22c2"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15)", "package_ndc": "0078-0684-15", "marketing_start_date": "20160822"}], "brand_name": "PROMACTA", "product_id": "0078-0684_b8a1cc48-9aaf-486a-9305-090acccb5c02", "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": "0078-0684", "generic_name": "eltrombopag olamine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMACTA", "active_ingredients": [{"name": "ELTROMBOPAG OLAMINE", "strength": "12.5 mg/1"}], "application_number": "NDA022291", "marketing_category": "NDA", "marketing_start_date": "20160822", "listing_expiration_date": "20261231"}