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United States · US · US:0078-1000_596d3b28-0dd7-4e01-9418-0d82372bf854
LEQVIO
Orange BookUNIISPLATC C10AX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeC10AX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100781000601 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS
- ndc1100781000981 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
UPC6BTX7PY
INCLISIRAN SODIUM
RxCUI 2588259
Orange Book
N214012
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UPC6BTX7PY",
"rxcui": "2588259",
"inchikey": null,
"display_name": "INCLISIRAN SODIUM",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"6fc0afca-4513-4c35-b594-6544aee29a44": {
"match": "brand_token",
"title": "LEQVIO (INCLISIRAN) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "12",
"published_date": "2026-02-16"
}
},
"productid": "0078-1000_596d3b28-0dd7-4e01-9418-0d82372bf854",
"productndc": "0078-1000",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214012",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)",
"product_no": "001",
"approval_date": "Dec 22, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INCLISIRAN SODIUM",
"proprietary_name": "LEQVIO",
"active_ingred_unit": "mg/1.5mL",
"application_number": "NDA214012",
"marketing_category": "NDA",
"nonproprietary_name": "inclisiran",
"start_marketing_date": "20211222",
"active_numerator_strength": "284"
}Related drugs
Other records sharing ATC code C10AX16.
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