69051-300 : Impavido 50 mg Oral Capsule

Labeler: Profounda, Inc.
Product Type: Human Prescription Drug
Drug Name:  Impavido
Dosage Form: Oral Capsule
Application #: NDA204684
Rev. Date: 


Shapes:  Capsule
Colors:  Red
Size (mm): 18
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:

  • 69051-300-01: 2 BLISTER PACK IN 1 CARTON (69051‑300‑01) > 14 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Miltefosine

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Cellulose, Microcrystalline
  • Lactose Monohydrate
  • Talc
  • Magnesium Stearate
  • Gelatin
  • Titanium Dioxide
  • Ferric Oxide Red
  • Water

Pharmaceutical Classes:

  • Antileishmanial [EPC]

Related Products:

Based on records with the same trade name.
  • 61744-050 Impavido 50 mg Oral Capsule by Paladin Therapeutics Inc.


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Note: The MedsChat® NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.