yargesa

Generic: miglustat

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name yargesa
Generic Name miglustat
Labeler edenbridge pharmaceuticals llc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

miglustat 100 mg/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-709
Product ID 42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209821
Listing Expiration 2026-12-31
Marketing Start 2020-08-06

Pharmacologic Class

Established (EPC)
glucosylceramide synthase inhibitor [epc] enzyme stabilizer [epc]
Mechanism of Action
glucosylceramide synthase inhibitors [moa] enzyme stabilizers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42799709
Hyphenated Format 42799-709

Supplemental Identifiers

RxCUI
401938 2642350
UNII
ADN3S497AZ
NUI
N0000175783 N0000020019 N0000194077 N0000194078

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 yargesa (source: ndc)
Generic Name miglustat (source: ndc)
Application Number ANDA209821 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

42799-709-15 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK

Ingredients (1)

miglustat (100 mg/1)

Linked Drug Pages (1)

Yargesa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462f6c9d-b8f1-3a76-e063-6294a90a2b50", "openfda": {"nui": ["N0000175783", "N0000020019", "N0000194077", "N0000194078"], "unii": ["ADN3S497AZ"], "rxcui": ["401938", "2642350"], "spl_set_id": ["2b371dfe-e2b0-47fe-b677-a7bde7149f87"], "pharm_class_epc": ["Glucosylceramide Synthase Inhibitor [EPC]", "Enzyme Stabilizer [EPC]"], "pharm_class_moa": ["Glucosylceramide Synthase Inhibitors [MoA]", "Enzyme Stabilizers [MoA]"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (42799-709-15)  / 15 CAPSULE in 1 BLISTER PACK", "package_ndc": "42799-709-15", "marketing_start_date": "20231031"}], "brand_name": "Yargesa", "product_id": "42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50", "dosage_form": "CAPSULE", "pharm_class": ["Enzyme Stabilizer [EPC]", "Enzyme Stabilizers [MoA]", "Glucosylceramide Synthase Inhibitor [EPC]", "Glucosylceramide Synthase Inhibitors [MoA]"], "product_ndc": "42799-709", "generic_name": "Miglustat", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Yargesa", "active_ingredients": [{"name": "MIGLUSTAT", "strength": "100 mg/1"}], "application_number": "ANDA209821", "marketing_category": "ANDA", "marketing_start_date": "20200806", "listing_expiration_date": "20261231"}