qfitlia

Generic: fitusiran

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name qfitlia
Generic Name fitusiran
Labeler genzyme corporation
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

fitusiran 50 mg/.5mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0348
Product ID 58468-0348_1c225007-61f2-4c48-a25e-f08b8d356a59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219019
Listing Expiration 2026-12-31
Marketing Start 2025-03-28

Pharmacologic Class

Established (EPC)
antithrombin-directed rna interaction [epc] small interfering rna [epc]
Chemical Structure
rna, small interfering [cs]
Physiologic Effect
decreased rna integrity [pe] increased rna degradation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680348
Hyphenated Format 58468-0348

Supplemental Identifiers

RxCUI
2709452 2709458 2709461 2709464
UNII
SV9W47ZLE1
NUI
N0000194148 N0000008852 N0000193848 M0406100 N0000194154

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 qfitlia (source: ndc)
Generic Name fitusiran (source: ndc)
Application Number NDA219019 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (58468-0348-1) / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

58468-0348-1 1 SYRINGE in 1 CARTON (58468-0348-1) / .5 mL in 1 SYRINGE

Ingredients (1)

fitusiran (50 mg/.5mL)

Linked Drug Pages (1)

Qfitlia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1c225007-61f2-4c48-a25e-f08b8d356a59", "openfda": {"nui": ["N0000194148", "N0000008852", "N0000193848", "M0406100", "N0000194154"], "unii": ["SV9W47ZLE1"], "rxcui": ["2709452", "2709458", "2709461", "2709464"], "spl_set_id": ["6dd2f8ac-6f90-4cbf-b197-97d74964135c"], "pharm_class_cs": ["RNA, Small Interfering [CS]"], "pharm_class_pe": ["Decreased RNA Integrity [PE]", "Increased RNA Degradation [PE]"], "pharm_class_epc": ["Antithrombin-directed RNA Interaction [EPC]", "Small Interfering RNA [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (58468-0348-1)  / .5 mL in 1 SYRINGE", "package_ndc": "58468-0348-1", "marketing_start_date": "20250328"}], "brand_name": "Qfitlia", "product_id": "58468-0348_1c225007-61f2-4c48-a25e-f08b8d356a59", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antithrombin-directed RNA Interaction [EPC]", "Decreased RNA Integrity [PE]", "Increased RNA Degradation [PE]", "RNA", "Small Interfering [CS]", "Small Interfering RNA [EPC]"], "product_ndc": "58468-0348", "generic_name": "fitusiran", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Qfitlia", "active_ingredients": [{"name": "FITUSIRAN", "strength": "50 mg/.5mL"}], "application_number": "NDA219019", "marketing_category": "NDA", "marketing_start_date": "20250328", "listing_expiration_date": "20261231"}