FDA.reportPublic FDA data

miltefosine 50 MG Oral Capsule [Impavido]

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
IngredientStrengthBaseBasis of strength
miltefosine50 MG / 1 EACHmiltefosinemiltefosine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
miltefosine1494066

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRImpavido 50 MG Oral Capsule1NAMES
RxNorm Namemiltefosine 50 MG Oral Capsule [Impavido]1NAMES
RxNorm SynonymImpavido 50 MG Oral Capsule1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDbcb387ac-2e90-4f5e-94b2-d3635190678e1CODES
RxCUI14950701CODES
MMSL_CODEBD260551CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
69051030001rxnav_ndcsyes
61744005001rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IMPAVIDOMILTEFOSINEProfounda, Inc.bcb387ac-2e90-4f5e-94b2-d3635190678e2026-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 69051030001
rxcui: 1495070

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 IDRxNorm mappingsTermsSPL versionLabelEffective
bcb387ac-2e90-4f5e-94b2-d3635190678eImpavido 50 MG Oral Capsule [PSN] · miltefosine 50 MG Oral Capsule [Impavido] [SBD] · Impavido 50 MG Oral Capsule [SY]313These 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: 201420251218

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
bcb387ac-2e90-4f5e-94b2-d3635190678eThese 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: 2014Profounda, Inc. | Haupt Pharma Amareg GmbH | Pharma Packaging Solutions, LLC dba TJOAPACK, LLC,20260930
bcb387ac-2e90-4f5e-94b2-d3635190678eThese 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: 2014Profounda, Inc. | Haupt Pharma Amareg GmbH | Pharma Packaging Solutions, LLC dba TJOAPACK, LLC,20251218

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCP01CXOther agents against leishmaniasis and trypanosomiasisATC1-4miltefosine
FDASPLN0000190851AntileishmanialEPChas_epcmiltefosine
MEDRTD010767PhosphorylcholineCHEMhas_ingredientmiltefosine
MEDRTD004342Drug HypersensitivityDISEASEci_withmiltefosine
MEDRTD016773Leishmaniasis, CutaneousDISEASEmay_treatmiltefosine
MEDRTD007898Leishmaniasis, VisceralDISEASEmay_treatmiltefosine
MEDRTD011247PregnancyDISEASEci_withmiltefosine
MEDRTD016111Sjogren-Larsson SyndromeDISEASEci_withmiltefosine
MEDRTN0000181812Lysophospholipid Receptor InteractionsMOAhas_moamiltefosine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH50 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA204684
NAMESPrescribable SynonymImpavido 50 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon