Home RxNorm 1495070 miltefosine 50 MG Oral Capsule [Impavido] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1495070
RxNorm name miltefosine 50 MG Oral Capsule [Impavido]
Display name IMPAVIDO (Oral Pill)
Full name miltefosine 50 MG Oral Capsule [Impavido]
Term type SBD
Status Active
Strength 50 mg
Dose form Cap
Route Oral Pill
Updated 2026-10-04 02:02:43 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 052014
Active start 052014
Multiple ingredient NO
Branded YES Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength miltefosine 50 MG / 1 EACH miltefosine miltefosine
Derived Ingredient Concepts# Ingredient, RxCUI table Ingredient RxCUI miltefosine 1494066
FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 69051-300-01 69051-300 IMPAVIDO miltefosine Profounda, Inc. NDA204684
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA204684 69051-300 IMPAVIDO miltefosine NDA Profounda, Inc.
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.
NDC11, Source, Active table NDC11 Source Active 69051030001 rxnav_ndcs yes 61744005001 rxnav_historical
UNII Substances# UNII substance links page 1 of 1 · 0 matching rows.
No records found.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings# unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.
Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective bcb387ac-2e90-4f5e-94b2-d3635190678e Impavido 50 MG Oral Capsule [PSN] · miltefosine 50 MG Oral Capsule [Impavido] [SBD] · Impavido 50 MG Oral Capsule [SY] 3 13 These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014 20251218
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective bcb387ac-2e90-4f5e-94b2-d3635190678e These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014 Profounda, Inc. | Haupt Pharma Amareg GmbH | Pharma Packaging Solutions, LLC dba TJOAPACK, LLC, 20261008 bcb387ac-2e90-4f5e-94b2-d3635190678e These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014 Profounda, Inc. | Haupt Pharma Amareg GmbH | Pharma Packaging Solutions, LLC dba TJOAPACK, LLC, 20260930 bcb387ac-2e90-4f5e-94b2-d3635190678e These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral use Initial U.S. Approval: 2014 Profounda, Inc. | Haupt Pharma Amareg GmbH | Pharma Packaging Solutions, LLC dba TJOAPACK, LLC, 20251218
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 50 MG ATTRIBUTES GENERAL_CARDINALITY SINGLE ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 CODES NDA NDA204684 NAMES Prescribable Synonym Impavido 50 MG Oral Capsule SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon