FDA.reportPublic FDA data

Qfitlia

Product NDC
58468-0348
11-digit product format
584680348
Labeler code
58468
Product ID
58468-0348_1c225007-61f2-4c48-a25e-f08b8d356a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fitusiran
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genzyme Corporation
Application
NDA219019
Marketing category
NDA
Marketing start
2025-03-28
Substance
FITUSIRAN
Active strength
50 mg/.5mL
Pharmacologic classes
Antithrombin-directed RNA Interaction [EPC], Decreased RNA Integrity [PE], Increased RNA Degradation [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Qfitlia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FITUSIRAN50 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSV9W47ZLE1
Rxcui2709452, 2709458, 2709461, 2709464

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55f688d6-ccc5-462b-be5a-e8613ba559edProduct name120260112
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0348-1Qfitlia0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.56
58468-0348-1Qfitlia1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0348-1ML - Milliliter58468-03487352a545-7376-4698-9d88-2901a668a53c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0348QFITLIA (FITUSIRAN) INJECTION, SOLUTION [GENZYME CORPORATION]3Current NDC, 2 package rows20250331_6dd2f8ac-6f90-4cbf-b197-97d74964135c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709452fitusiran 20 MG in 0.2 ML InjectionPSN6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709461fitusiran 50 MG in 0.5 ML Auto-InjectorPSN6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709458Qfitlia 20 MG in 0.2 ML InjectionPSN6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709464Qfitlia 50 MG in 0.5 ML Auto-InjectorPSN6dd2f8ac-6f90-4cbf-b197-97d74964135c6
27094580.2 ML fitusiran 100 MG/ML Injection [Qfitlia]SBD6dd2f8ac-6f90-4cbf-b197-97d74964135c6
27094640.5 ML fitusiran 100 MG/ML Auto-Injector [Qfitlia]SBD6dd2f8ac-6f90-4cbf-b197-97d74964135c6
27094520.2 ML fitusiran 100 MG/ML InjectionSCD6dd2f8ac-6f90-4cbf-b197-97d74964135c6
27094610.5 ML fitusiran 100 MG/ML Auto-InjectorSCD6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709452fitusiran 20 MG per 0.2 ML InjectionSY6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709461fitusiran 50 MG per 0.5 ML Auto-InjectorSY6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709458Qfitlia 20 MG per 0.2 ML InjectionSY6dd2f8ac-6f90-4cbf-b197-97d74964135c6
2709464Qfitlia 50 MG per 0.5 ML Auto-InjectorSY6dd2f8ac-6f90-4cbf-b197-97d74964135c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58468-0348-1584680348011 SYRINGE in 1 CARTON (58468-0348-1) / .5 mL in 1 SYRINGE1 syringe2025-03-28NoNoCurrent