Prescription drug · NDA
Vyondys 53 (Golodirsen) NDC 60923-465
Golodirsen 50 mg/mL · Injection · Intravenous · Sarepta Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60923-465-02 | 60923046502 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) / 2 mL in 1 VIAL, SINGLE-USEMarketed from Dec 12, 2019 |
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)
- Vyondys 53
- Generic name (nonproprietary)
- golodirsen
- Active ingredients
- Golodirsen — 50 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sarepta Therapeutics, Inc.NDC labeler code 60923
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211970
- Marketing start
- Listing expires
- Other FDA classes
- Increased Protein Synthesis (Physiologic effect)Antisense (Chemical structure)
- Identifiers
- Product ID 60923-465_5fbaac76-f7cb-4f43-99f8-af43c2655ff0SPL ID 5fbaac76-f7cb-4f43-99f8-af43c2655ff0SPL set ID 35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5RxCUI 2267211, 2267216UNII 033072U4MZ
- 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.
- 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
N460923046502followed by a unit qualifier and the quantityPackage 60923-0465-02. 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)
VYONDYS 53 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 VYONDYS 53 [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. VYONDYS 53 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 skipping. Thi…
Excerpt only. Read the full label for complete information.
About NDC 60923-465
- What is NDC 60923-465?
- 60923-465 is the product NDC for Vyondys 53 (golodirsen), Golodirsen 50 mg/mL injection, listed with the FDA by Sarepta Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vyondys 53 (Golodirsen).
- What is the active ingredient?
- Golodirsen.
- Who is the labeler?
- Sarepta Therapeutics, Inc., NDC labeler code 60923. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vyondys 53?
- 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.