cerdelga

Generic: eliglustat

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cerdelga
Generic Name eliglustat
Labeler genzyme corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

eliglustat 84 mg/1

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0220
Product ID 58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205494
Listing Expiration 2026-12-31
Marketing Start 2014-09-03

Pharmacologic Class

Established (EPC)
glucosylceramide synthase inhibitor [epc]
Mechanism of Action
glucosylceramide synthase inhibitors [moa] p-glycoprotein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680220
Hyphenated Format 58468-0220

Supplemental Identifiers

RxCUI
1547225 1547231
UNII
DR40J4WA67
NUI
N0000175783 N0000020019 N0000185503 N0000182137

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 cerdelga (source: ndc)
Generic Name eliglustat (source: ndc)
Application Number NDA205494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 84 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

58468-0220-1 4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK 58468-0220-2 1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK

Ingredients (1)

eliglustat (84 mg/1)

Linked Drug Pages (1)

Cerdelga ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e71b0b39-5a29-4e38-8500-55b6d1f48543", "openfda": {"nui": ["N0000175783", "N0000020019", "N0000185503", "N0000182137"], "unii": ["DR40J4WA67"], "rxcui": ["1547225", "1547231"], "spl_set_id": ["819f828a-b888-4e46-83fc-94d774a28a83"], "pharm_class_epc": ["Glucosylceramide Synthase Inhibitor [EPC]"], "pharm_class_moa": ["Glucosylceramide Synthase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58468-0220-1)  / 14 CAPSULE in 1 BLISTER PACK", "package_ndc": "58468-0220-1", "marketing_start_date": "20140903"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58468-0220-2)  / 14 CAPSULE in 1 BLISTER PACK", "package_ndc": "58468-0220-2", "marketing_start_date": "20140903"}], "brand_name": "Cerdelga", "product_id": "58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Glucosylceramide Synthase Inhibitor [EPC]", "Glucosylceramide Synthase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "58468-0220", "generic_name": "eliglustat", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cerdelga", "active_ingredients": [{"name": "ELIGLUSTAT", "strength": "84 mg/1"}], "application_number": "NDA205494", "marketing_category": "NDA", "marketing_start_date": "20140903", "listing_expiration_date": "20261231"}