Package 68475-204-04
Brand: miglustat
Generic: miglustatPackage Facts
Identity
Package NDC
68475-204-04
Digits Only
6847520404
Product NDC
68475-204
Description
4 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03)
Marketing
Marketing Status
Brand
miglustat
Generic
miglustat
Sample Package
No
Linked Drug Pages (1)
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"}