NDC 69051-300

IMPAVIDO

Miltefosine

IMPAVIDO is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Profounda, Inc.. The primary component is Miltefosine.

• Product ID: 69051-300_3a963cdb-21bb-4e19-9a0f-191c357c4b9f
• NDC: 69051-300
• Product Type: Human Prescription Drug
• Proprietary Name: IMPAVIDO
• Generic Name: Miltefosine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-29
• Marketing Category: NDA / NDA
• Application Number: NDA204684
• Labeler Name: Profounda, Inc.
• Substance Name: MILTEFOSINE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Antileishmanial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 69051-300-01

2 BLISTER PACK in 1 CARTON (69051-300-01) > 14 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2015-10-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69051-300-01 [69051030001]

IMPAVIDO CAPSULE

• Marketing Category: NDA
• Application Number: NDA204684
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-29

Drug Details

Active Ingredients

Ingredient	Strength
MILTEFOSINE	50 mg/1

OpenFDA Data

• SPL SET ID: bcb387ac-2e90-4f5e-94b2-d3635190678e
• Manufacturer:
  • Profounda, Inc.
• UNII:
  • 53EY29W7EC
• RxNorm Concept Unique ID - RxCUI:
  • 1494071
  • 1495070

Pharmacological Class

• Antileishmanial [EPC]