0078-0684 : Promacta 12.5 mg Oral Tablet, Film Coated

Labeler: Novartis Pharmaceuticals Corporation
Product Type: Human Prescription Drug
Drug Name:  Promacta
Dosage Form: Oral Tablet, Film Coated
Application #: NDA022291
Rev. Date: 


Markings: GS;MZ1;125
Shapes:  Round
Colors:  White
Size (mm): 10
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0078-0684-15: 30 TABLET, FILM COATED IN 1 BOTTLE (0078‑0684‑15)

Active Ingredients:

  • Eltrombopag Olamine

Dosage Strength:

  • 12.5 mg

Inactive Ingredients:

  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Povidones
  • Sodium Starch Glycolate Type a Potato
  • Hypromelloses
  • Polyethylene Glycol 400
  • Titanium Dioxide
  • Ferric Oxide Red
  • Ferrosoferric Oxide

Pharmaceutical 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]

Related Products:

Based on records with the same trade name.
  • 0078-0685 Promacta 25 mg Oral Tablet, Film Coated by Novartis Pharmaceuticals Corporation
  • 0078-0686 Promacta 50 mg Oral Tablet, Film Coated by Novartis Pharmaceuticals Corporation
  • 0078-0687 Promacta 75 mg Oral Tablet, Film Coated by Novartis Pharmaceuticals Corporation
  • 0078-0972 Promacta 12.5 mg Oral Powder, for Suspension by Novartis Pharmaceuticals Corporation
  • 0007-4640 Promacta 25 mg Oral Tablet by Glaxosmithkline LLC
  • 0007-4641 Promacta 50 mg Oral Tablet by Glaxosmithkline LLC
  • 0007-4642 Promacta 75 mg Oral Tablet by Glaxosmithkline LLC
  • 0007-4643 Promacta 12.5 mg Oral Tablet by Glaxosmithkline LLC
  • 0007-4644 Promacta 100 mg Oral Tablet by Glaxosmithkline LLC
  • 0007-4646 Promacta 100 mg/1 Oral Tablet, Film Coated by Glaxosmithkline LLC


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