Prescription drug · NDA
Qfitlia (Fitusiran) NDC 58468-0348
Fitusiran 50 mg/.5mL · Injection, Solution · Subcutaneous · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0348-1 | 58468034801 | 1 SYRINGE in 1 CARTON (58468-0348-1) / .5 mL in 1 SYRINGEMarketed from Mar 28, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Qfitlia
- Generic name (nonproprietary)
- fitusiran
- Active ingredients
- Fitusiran — 50 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219019
- Marketing start
- Listing expires
- Other FDA classes
- Decreased RNA Integrity (Physiologic effect)Increased RNA Degradation (Physiologic effect)Small Interfering (Chemical structure)
- Identifiers
- Product ID 58468-0348_1c225007-61f2-4c48-a25e-f08b8d356a59SPL ID 1c225007-61f2-4c48-a25e-f08b8d356a59SPL set ID 6dd2f8ac-6f90-4cbf-b197-97d74964135cRxCUI 2709452, 2709458, 2709461, 2709464UNII SV9W47ZLE1
- Pharmacologic class
- Antithrombin-directed RNA Interaction; Small Interfering RNA
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N458468034801followed by a unit qualifier and the quantityPackage 58468-0348-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0348
- What is NDC 58468-0348?
- 58468-0348 is the product NDC for Qfitlia (fitusiran), Fitusiran 50 mg/.5mL injection, solution, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qfitlia (Fitusiran).
- What is the active ingredient?
- Fitusiran.
- Who is the labeler?
- Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qfitlia?
- 1 other product NDC are listed under this name. See all Qfitlia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Qfitlia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Qfitliafitusiran | Fitusiran 20 mg/.2mL | Injection, SolutionSubcutaneous | Genzyme Corporation | 58468-0347 | 58468-0347-01 |
Other NDCs under NDA 219019
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Qfitliafitusiran | Fitusiran 20 mg/.2mL | Injection, SolutionSubcutaneous | Genzyme Corporation | 58468-0347 |