impavido

Generic: miltefosine

Labeler: profounda, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name impavido
Generic Name miltefosine
Labeler profounda, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

miltefosine 50 mg/1

Manufacturer
Profounda, Inc.

Identifiers & Regulatory

Product NDC 69051-300
Product ID 69051-300_463f0c82-b948-2b96-e063-6394a90aecf0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204684
Listing Expiration 2027-12-31
Marketing Start 2015-10-29

Pharmacologic Class

Established (EPC)
antileishmanial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69051300
Hyphenated Format 69051-300

Supplemental Identifiers

RxCUI
1494071 1495070
UNII
53EY29W7EC
NUI
N0000190851

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name impavido (source: ndc)
Generic Name miltefosine (source: ndc)
Application Number NDA204684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

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

Ingredients (1)

miltefosine (50 mg/1)

Linked Drug Pages (1)

IMPAVIDO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "463f0c82-b948-2b96-e063-6394a90aecf0", "openfda": {"nui": ["N0000190851"], "unii": ["53EY29W7EC"], "rxcui": ["1494071", "1495070"], "spl_set_id": ["bcb387ac-2e90-4f5e-94b2-d3635190678e"], "pharm_class_epc": ["Antileishmanial [EPC]"], "manufacturer_name": ["Profounda, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69051-300-01)  / 14 CAPSULE in 1 BLISTER PACK", "package_ndc": "69051-300-01", "marketing_start_date": "20151029"}], "brand_name": "IMPAVIDO", "product_id": "69051-300_463f0c82-b948-2b96-e063-6394a90aecf0", "dosage_form": "CAPSULE", "pharm_class": ["Antileishmanial [EPC]"], "product_ndc": "69051-300", "generic_name": "miltefosine", "labeler_name": "Profounda, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMPAVIDO", "active_ingredients": [{"name": "MILTEFOSINE", "strength": "50 mg/1"}], "application_number": "NDA204684", "marketing_category": "NDA", "marketing_start_date": "20151029", "listing_expiration_date": "20271231"}