leqvio

Generic: inclisiran

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name leqvio
Generic Name inclisiran
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

inclisiran sodium 284 mg/1.5mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1000
Product ID 0078-1000_596d3b28-0dd7-4e01-9418-0d82372bf854
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214012
Listing Expiration 2027-12-31
Marketing Start 2021-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781000
Hyphenated Format 0078-1000

Supplemental Identifiers

RxCUI
2588263 2588269
UNII
UPC6BTX7PY

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 leqvio (source: ndc)
Generic Name inclisiran (source: ndc)
Application Number NDA214012 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 284 mg/1.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

0078-1000-60 1 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS 0078-1000-98 1 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS

Ingredients (1)

inclisiran sodium (284 mg/1.5mL)

Linked Drug Pages (1)

LEQVIO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "596d3b28-0dd7-4e01-9418-0d82372bf854", "openfda": {"unii": ["UPC6BTX7PY"], "rxcui": ["2588263", "2588269"], "spl_set_id": ["6fc0afca-4513-4c35-b594-6544aee29a44"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1000-60)  / 1.5 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1000-60", "marketing_start_date": "20211222"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (0078-1000-98)  / 1.5 mL in 1 SYRINGE, GLASS", "package_ndc": "0078-1000-98", "marketing_start_date": "20230217"}], "brand_name": "LEQVIO", "product_id": "0078-1000_596d3b28-0dd7-4e01-9418-0d82372bf854", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0078-1000", "generic_name": "inclisiran", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEQVIO", "active_ingredients": [{"name": "INCLISIRAN SODIUM", "strength": "284 mg/1.5mL"}], "application_number": "NDA214012", "marketing_category": "NDA", "marketing_start_date": "20211222", "listing_expiration_date": "20271231"}