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United States · US · US:58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543
Cerdelga
Orange BookUNIISPLATC A16AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenzyme Corporation
CountryUS (United States)
ATC codeA16AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1158468022014 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK
- ndc1158468022021 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
DR40J4WA67
ELIGLUSTAT
RxCUI 1547220
Orange Book
N205494
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DR40J4WA67",
"rxcui": "1547220",
"inchikey": "FJZZPCZKBUKGGU-AUSIDOKSSA-N",
"display_name": "ELIGLUSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"819f828a-b888-4e46-83fc-94d774a28a83": {
"match": "brand_token",
"title": "CERDELGA (ELIGLUSTAT) CAPSULE [GENZYME CORPORATION]",
"spl_version": "13",
"published_date": "2024-03-11"
}
},
"productid": "58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543",
"productndc": "58468-0220",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205494",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 84MG BASE",
"product_no": "001",
"approval_date": "Aug 19, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ELIGLUSTAT",
"proprietary_name": "Cerdelga",
"active_ingred_unit": "mg/1",
"application_number": "NDA205494",
"marketing_category": "NDA",
"nonproprietary_name": "eliglustat",
"start_marketing_date": "20140903",
"active_numerator_strength": "84"
}Related drugs
Other records sharing ATC code A16AX10.
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