FDA.reportPublic FDA data

LEQVIO

Product NDC
0078-1000
11-digit product format
000781000
Labeler code
0078
Product ID
0078-1000_596d3b28-0dd7-4e01-9418-0d82372bf854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
inclisiran
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA214012
Marketing category
NDA
Marketing start
2021-12-22
Substance
INCLISIRAN SODIUM
Active strength
284 mg/1.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEQVIO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INCLISIRAN SODIUM284 mg/1.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUPC6BTX7PY
Rxcui2588263, 2588269

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3af4c60-042e-40f5-aa94-6e69117ebcbcProduct name120220901

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1000-60LEQVIO1.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.512
0078-1000-60LEQVIO1 in 1 CARTONINJECTION, SOLUTION112
0078-1000-98LEQVIO1.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.512
0078-1000-98LEQVIO1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1000-60ML - Milliliter0078-100009f9f077-74ae-4824-b093-6553f072bc2c12022-01-06
0078-1000-98ML - Milliliter0078-100056970c80-13c7-41e5-81e1-77ecb65478e412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1000LEQVIO (INCLISIRAN) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]9Current NDC, Legacy NDC, 4 package rows20240710_6fc0afca-4513-4c35-b594-6544aee29a44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588263inclisiran 284 MG in 1.5 ML Prefilled SyringePSN6fc0afca-4513-4c35-b594-6544aee29a4412
2588269LEQVIO 284 MG in 1.5 ML Prefilled SyringePSN6fc0afca-4513-4c35-b594-6544aee29a4412
25882691.5 ML inclisiran 189 MG/ML Prefilled Syringe [Leqvio]SBD6fc0afca-4513-4c35-b594-6544aee29a4412
25882631.5 ML inclisiran 189 MG/ML Prefilled SyringeSCD6fc0afca-4513-4c35-b594-6544aee29a4412
25882691.5 ML Leqvio 189 MG/ML Prefilled SyringeSY6fc0afca-4513-4c35-b594-6544aee29a4412
2588263inclisiran 284 MG per 1.5 ML Prefilled SyringeSY6fc0afca-4513-4c35-b594-6544aee29a4412
2588269Leqvio 284 MG (equivalent to 300 MG inclisiran sodium) per 1.5 ML Prefilled SyringeSY6fc0afca-4513-4c35-b594-6544aee29a4412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-1000-60000781000601 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS2021-12-220000-00-00NoNoCurrent
0078-1000-98000781000981 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS2023-02-17YesNoCurrent