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United States · US · US:75929-027_4b213a81-7f56-a734-e063-6394a90a07e6
Juxtapid
Orange BookUNIISPLATC C10AX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharma Packaging Solutions, LLC dba Tjoapack LLC
CountryUS (United States)
ATC codeC10AX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11759290272528 CAPSULE in 1 BOTTLE (75929-027-25)
- ndc11759290275128 CAPSULE in 1 BOTTLE (75929-027-51)
- ndc11759290275228 CAPSULE in 1 BOTTLE (75929-027-52)
Annotations
UNII (FDA Substance ID)
X4S83CP54E
LOMITAPIDE MESYLATE
RxCUI 1364478
Orange Book
N203858
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X4S83CP54E",
"rxcui": "1364478",
"inchikey": "QKVKOFVWUHNEBX-UHFFFAOYSA-N",
"display_name": "LOMITAPIDE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"61a0be9d-ee58-43e0-b5cb-141011835081": {
"match": "brand_token",
"title": "JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [CHIESI USA, INC.]",
"spl_version": "25",
"published_date": "2026-04-02"
}
},
"productid": "75929-027_4b213a81-7f56-a734-e063-6394a90a07e6",
"productndc": "75929-027",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203858",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Dec 21, 2012"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Dec 21, 2012"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "003",
"approval_date": "Dec 21, 2012"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "004",
"approval_date": "Apr 23, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "005",
"approval_date": "Apr 23, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "006",
"approval_date": "Apr 23, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 2MG BASE",
"product_no": "007",
"approval_date": "Feb 25, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOMITAPIDE MESYLATE",
"proprietary_name": "Juxtapid",
"active_ingred_unit": "mg/1",
"application_number": "NDA203858",
"marketing_category": "NDA",
"nonproprietary_name": "lomitapide mesylate",
"start_marketing_date": "20130103",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C10AX12.
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