NDC 0078-0686

PROMACTA

Eltrombopag Olamine

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

• Product ID: 0078-0686_11b31b9a-d218-4406-bac5-ee975277918a
• NDC: 0078-0686
• Product Type: Human Prescription Drug
• Proprietary Name: PROMACTA
• Generic Name: Eltrombopag Olamine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-07
• Marketing Category: NDA / NDA
• Application Number: NDA022291
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: ELTROMBOPAG OLAMINE
• Active Ingredient Strength: 50 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
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0686-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15)

• Marketing Start Date: 2016-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0686-55 [00078068655]

PROMACTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022291
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-21

NDC 0078-0686-15 [00078068615]

PROMACTA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022291
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-07

Drug Details

Active Ingredients

Ingredient	Strength
ELTROMBOPAG OLAMINE	50 mg/1

OpenFDA Data

• SPL SET ID: 7714a0ed-34bb-46e6-a0a5-b363908b22c2
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 4U07F515LG
• RxNorm Concept Unique ID - RxCUI:
  • 825421
  • 884619
  • 825425
  • 1245001
  • 825427
  • 825429
  • 884617
  • 2058981
  • 2058980
  • 1245003

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