miglustat

Generic: miglustat

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miglustat
Generic Name miglustat
Labeler navinta llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

miglustat 100 mg/1

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-204
Product ID 68475-204_94491d95-3cdd-45cd-b94c-a0d4982618cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219111
Listing Expiration 2026-12-31
Marketing Start 2025-05-07

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 68475204
Hyphenated Format 68475-204

Supplemental Identifiers

RxCUI
401938
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 miglustat (source: ndc)
Generic Name miglustat (source: ndc)
Application Number ANDA219111 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01)
  • 4 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03)
source: ndc

Packages (2)

68475-204-02 6 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01) 68475-204-04 4 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03)

Ingredients (1)

miglustat (100 mg/1)

Linked Drug Pages (1)

Miglustat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "94491d95-3cdd-45cd-b94c-a0d4982618cc", "openfda": {"nui": ["N0000175783", "N0000020019", "N0000194077", "N0000194078"], "unii": ["ADN3S497AZ"], "rxcui": ["401938"], "spl_set_id": ["aa9a3ab6-2376-4b52-9e54-15dc87f25260"], "pharm_class_epc": ["Glucosylceramide Synthase Inhibitor [EPC]", "Enzyme Stabilizer [EPC]"], "pharm_class_moa": ["Glucosylceramide Synthase Inhibitors [MoA]", "Enzyme Stabilizers [MoA]"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (68475-204-02)  / 15 CAPSULE in 1 BLISTER PACK (68475-204-01)", "package_ndc": "68475-204-02", "marketing_start_date": "20250507"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68475-204-04)  / 21 CAPSULE in 1 BLISTER PACK (68475-204-03)", "package_ndc": "68475-204-04", "marketing_start_date": "20251223"}], "brand_name": "Miglustat", "product_id": "68475-204_94491d95-3cdd-45cd-b94c-a0d4982618cc", "dosage_form": "CAPSULE", "pharm_class": ["Enzyme Stabilizer [EPC]", "Enzyme Stabilizers [MoA]", "Glucosylceramide Synthase Inhibitor [EPC]", "Glucosylceramide Synthase Inhibitors [MoA]"], "product_ndc": "68475-204", "generic_name": "Miglustat", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Miglustat", "active_ingredients": [{"name": "MIGLUSTAT", "strength": "100 mg/1"}], "application_number": "ANDA219111", "marketing_category": "ANDA", "marketing_start_date": "20250507", "listing_expiration_date": "20261231"}