Prescription drug · NDA
Qalsody (Tofersen) NDC 64406-109
Tofersen 100 mg/15mL · Injection · Intrathecal · Biogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-109-01 | 6440601090164406010901 | 1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USEMarketed from Apr 25, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Qalsody
- Generic name (nonproprietary)
- tofersen
- Active ingredients
- Tofersen — 100 mg/15mL
- Dosage form
- Injection
- Route
- Intrathecal
- Labeler
- Biogen Inc.NDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215887
- Marketing start
- Listing expires
- Other FDA classes
- Antisense (Chemical structure)
- Identifiers
- Product ID 64406-109_cd6631f3-a134-4743-81b1-ede10394e394SPL ID cd6631f3-a134-4743-81b1-ede10394e394SPL set ID 81356b45-1cb7-4eef-88ea-e44cc18b47c5RxCUI 2634999, 2635005UNII 2NU6F9601KUPC 0364406109010
- Pharmacologic class
- Antisense Oligonucleotide
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.
- NDC on a medical claim
N464406010901followed by a unit qualifier and the quantityPackage 64406-0109-01. 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 .
Indications (excerpt from the label)
QALSODY is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). QALSODY is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This indication is approved under accelerated approval…
Excerpt only. Read the full label for complete information.
About NDC 64406-109
- What is NDC 64406-109?
- 64406-109 is the product NDC for Qalsody (tofersen), Tofersen 100 mg/15mL injection, listed with the FDA by Biogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qalsody (Tofersen).
- What is the active ingredient?
- Tofersen.
- Who is the labeler?
- Biogen Inc., NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qalsody?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.