NDC 0007-4640

PROMACTA

Eltrombopag Olamine

PROMACTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Eltrombopag Olamine.

• Product ID: 0007-4640_c7c46a73-1f77-45f6-ab60-1aa8f9e87463
• NDC: 0007-4640
• Product Type: Human Prescription Drug
• Proprietary Name: PROMACTA
• Generic Name: Eltrombopag Olamine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-11-24
• Marketing End Date: 2019-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA022291
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: ELTROMBOPAG OLAMINE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0007-4640-13

30 TABLET, FILM COATED in 1 BOTTLE (0007-4640-13)

• Marketing Start Date: 2008-11-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0007-4640-13 [00007464013]

PROMACTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022291
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-11-24
• Marketing End Date: 2019-04-30

Drug Details

Active Ingredients

Ingredient	Strength
ELTROMBOPAG OLAMINE	25 mg/1

OpenFDA Data

• SPL SET ID: 616224ff-a925-4b38-9ca2-00fbf669380f
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 4U07F515LG
• RxNorm Concept Unique ID - RxCUI:
  • 825421
  • 884619
  • 1364583
  • 825425
  • 1245001
  • 825427
  • 1859498
  • 825429
  • 1859501
  • 884617
  • 1245003
  • 1364585

Pharmacological Class

• Increased Megakaryocyte Maturation [PE]
• Increased Platelet Production [PE]
• Thrombopoietin Receptor Agonist [EPC]
• Thrombopoietin Receptor Agonists [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• UGT1A1 Inhibitors [MoA]
• UGT1A3 Inhibitors [MoA]
• UGT1A4 Inhibitors [MoA]
• UGT1A6 Inhibitors [MoA]
• UGT1A9 Inhibitors [MoA]
• UGT2B7 Inhibitors [MoA]
• UGT2B15 Inhibitors [MoA]

NDC Crossover Matching brand name "PROMACTA" or generic name "Eltrombopag Olamine"

NDC	Brand Name	Generic Name
0007-4640	PROMACTA	eltrombopag olamine
0007-4641	PROMACTA	eltrombopag olamine
0007-4642	PROMACTA	eltrombopag olamine
0007-4643	PROMACTA	eltrombopag olamine
0078-0684	PROMACTA	eltrombopag olamine
0078-0685	PROMACTA	eltrombopag olamine
0078-0686	PROMACTA	eltrombopag olamine
0078-0687	PROMACTA	eltrombopag olamine
0078-0697	PROMACTA	eltrombopag olamine
0078-0972	PROMACTA	PROMACTA