Prescription drug · NDA
Exondys 51 (Eteplirsen) NDC 60923-363
Eteplirsen 50 mg/mL · Injection · Intravenous · Sarepta Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60923-363-02 | 60923036302 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) / 2 mL in 1 VIAL, SINGLE-USEMarketed from Sep 19, 2016 |
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)
- Exondys 51
- Generic name (nonproprietary)
- eteplirsen
- Active ingredients
- Eteplirsen — 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 206488
- Marketing start
- Listing expires
- Other FDA classes
- Antisense (Chemical structure)
- Identifiers
- Product ID 60923-363_97565339-f295-43ab-98a9-bb6bdf2d049cSPL ID 97565339-f295-43ab-98a9-bb6bdf2d049cSPL set ID 33bff678-7829-479e-9110-b8e33a0bc0aaRxCUI 1810573, 1810578, 1810581, 1810582UNII AIW6036FASUPC 0360923284100, 0360923363027
- 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
N460923036302followed by a unit qualifier and the quantityPackage 60923-0363-02. 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)
EXONDYS 51 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 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51 [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. EXONDYS 51 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 51 skipping. This indi…
Excerpt only. Read the full label for complete information.
About NDC 60923-363
- What is NDC 60923-363?
- 60923-363 is the product NDC for Exondys 51 (eteplirsen), Eteplirsen 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?
- Exondys 51 (Eteplirsen).
- What is the active ingredient?
- Eteplirsen.
- 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 Exondys 51?
- 1 other product NDC are listed under this name. See all Exondys 51 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exondys 51 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exondys 51eteplirsen | Eteplirsen 50 mg/mL | InjectionIntravenous | Sarepta Therapeutics, Inc. | 60923-284 | 60923-0284-10 |
Other NDCs under NDA 206488
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 |
|---|---|---|---|---|
| Exondys 51eteplirsen | Eteplirsen 50 mg/mL | InjectionIntravenous | Sarepta Therapeutics, Inc. | 60923-284 |