FDA.reportPublic FDA data

IMPAVIDO

Product NDC
69051-300
11-digit product format
690510300
Labeler code
69051
Product ID
69051-300_463f0c82-b948-2b96-e063-6394a90aecf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
miltefosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Profounda, Inc.
Application
NDA204684
Marketing category
NDA
Marketing start
2015-10-29
Marketing end
2026-09-26
Substance
MILTEFOSINE
Active strength
50 mg/1
Pharmacologic classes
Antileishmanial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IMPAVIDO

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILTEFOSINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53EY29W7EC
Rxcui1494071, 1495070

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a89d3c9-797a-49cb-baae-69b17c58745cProduct name120140721

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69051-300-012023-05-08C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012023-05-08C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012023-01-30C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012023-01-30C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012021-03-04C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012021-03-04C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012021-01-29C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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
69051-300-012021-01-29C16284748780-1ba0f9c33-3ba9-a910-e053-dadaa90a0b85These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69051-300-01IMPAVIDO2 in 1 CARTONCAPSULE213
69051-300-01IMPAVIDO14 in 1 BLISTER PACKCAPSULE1413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69051-300-01EA - Each69051-300c0f00f9d-ed75-47ec-843b-6af57b1a413a12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MILTEFOSINEACTIVE INGREDIENT53EY29W7ECIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
MILTEFOSINEACTIVE MOIETY53EY29W7ECIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69051-300IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]12Current NDC, Legacy NDC, 2 package rows20250426_bcb387ac-2e90-4f5e-94b2-d3635190678e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1495070Impavido 50 MG Oral CapsulePSNbcb387ac-2e90-4f5e-94b2-d3635190678e13
1494071miltefosine 50 MG Oral CapsulePSNbcb387ac-2e90-4f5e-94b2-d3635190678e13
1495070miltefosine 50 MG Oral Capsule [Impavido]SBDbcb387ac-2e90-4f5e-94b2-d3635190678e13
1494071miltefosine 50 MG Oral CapsuleSCDbcb387ac-2e90-4f5e-94b2-d3635190678e13
1495070Impavido 50 MG Oral CapsuleSYbcb387ac-2e90-4f5e-94b2-d3635190678e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69051-300-01690510300012 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK2 blister pack2015-10-290000-00-00NoNoCurrent