zavesca

Generic: miglustat

Labeler: actelion pharmaceuticals us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zavesca
Generic Name miglustat
Labeler actelion pharmaceuticals us, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

miglustat 100 mg/1

Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-201
Product ID 66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021348
Listing Expiration 2026-12-31
Marketing Start 2003-07-31

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 66215201
Hyphenated Format 66215-201

Supplemental Identifiers

RxCUI
401938 541070
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 zavesca (source: ndc)
Generic Name miglustat (source: ndc)
Application Number NDA021348 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)
source: ndc

Packages (1)

66215-201-90 6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)

Ingredients (1)

miglustat (100 mg/1)

Linked Drug Pages (1)

Zavesca ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f9cb16ee-d325-b331-e053-6394a90ab08c", "openfda": {"nui": ["N0000175783", "N0000020019", "N0000194077", "N0000194078"], "unii": ["ADN3S497AZ"], "rxcui": ["401938", "541070"], "spl_set_id": ["817892d1-ee12-4632-85fc-57ccdf16d7b8"], "pharm_class_epc": ["Glucosylceramide Synthase Inhibitor [EPC]", "Enzyme Stabilizer [EPC]"], "pharm_class_moa": ["Glucosylceramide Synthase Inhibitors [MoA]", "Enzyme Stabilizers [MoA]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (66215-201-90)  / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)", "package_ndc": "66215-201-90", "marketing_start_date": "20030731"}], "brand_name": "Zavesca", "product_id": "66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c", "dosage_form": "CAPSULE", "pharm_class": ["Glucosylceramide Synthase Inhibitor [EPC]", "Glucosylceramide Synthase Inhibitors [MoA]"], "product_ndc": "66215-201", "generic_name": "miglustat", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zavesca", "active_ingredients": [{"name": "MIGLUSTAT", "strength": "100 mg/1"}], "application_number": "NDA021348", "marketing_category": "NDA", "marketing_start_date": "20030731", "listing_expiration_date": "20261231"}