Prescription drug · NDA
Viltepso (Viltolarsen) NDC 73292-011
Viltolarsen 250 mg/1 · Injection, Solution · Intravenous · NS Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73292-011-01 | 73292001101 | 1 VIAL, GLASS in 1 CARTON (73292-011-01) / 1 INJECTION, SOLUTION in 1 VIAL, GLASSMarketed from Aug 13, 2020 |
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)
- Viltepso
- Generic name (nonproprietary)
- viltolarsen
- Active ingredients
- Viltolarsen — 250 mg/1
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- NS Pharma, Inc.NDC labeler code 73292
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212154
- Marketing start
- Listing expires
- Identifiers
- Product ID 73292-011_0e3b8e29-64dd-430f-998d-5aca82258a8dSPL ID 0e3b8e29-64dd-430f-998d-5aca82258a8dSPL set ID 1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123RxCUI 2389844, 2389849UNII SXA7YP6EKX
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
N473292001101followed by a unit qualifier and the quantityPackage 73292-0011-01. 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)
VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. VILTEPSO is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipp…
Excerpt only. Read the full label for complete information.
About NDC 73292-011
- What is NDC 73292-011?
- 73292-011 is the product NDC for Viltepso (viltolarsen), Viltolarsen 250 mg/1 injection, solution, listed with the FDA by NS Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Viltepso (Viltolarsen).
- What is the active ingredient?
- Viltolarsen.
- Who is the labeler?
- NS Pharma, Inc., NDC labeler code 73292. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Viltepso?
- 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.