Prescription drug · BLA
Otarmeni (Lunsotogene parvec-cwha) NDC 61755-062
Lunsotogene parvec 30000000000000 {GC}/mL · Injection, Solution · Intracochlear · Regeneron Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61755-062-99 | 61755006299 | 1 CARTON in 1 BAG (61755-062-99) / 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-062-01) / 1 mL in 1 VIAL, SINGLE-DOSE (61755-062-00)Marketed from Apr 23, 2026 |
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)
- Otarmeni
- Generic name (nonproprietary)
- lunsotogene parvec-cwha
- Active ingredients
- Lunsotogene parvec — 30000000000000 {GC}/mL
- Dosage form
- Injection, Solution
- Route
- Intracochlear
- Labeler
- Regeneron Pharmaceuticals, Inc.NDC labeler code 61755
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125874
- Marketing start
- Listing expires
- Identifiers
- Product ID 61755-062_8a9f9446-ae96-4c9e-addc-7d6006a8dcebSPL ID 8a9f9446-ae96-4c9e-addc-7d6006a8dcebSPL set ID a7a5e936-ab4a-4609-ac10-96efedc89035RxCUI 2741622, 2741629UNII P6ZNU67HPU
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
N461755006299followed by a unit qualifier and the quantityPackage 61755-0062-99. 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)
OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. This indication is approved under accelerated approval based on the improvement of hearing sensitivity assessed by average pure tone audiometry (PTA) at Week 24 [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory clinical trial. Limitations of Use OTARMENI is not recomm…
Excerpt only. Read the full label for complete information.
About NDC 61755-062
- What is NDC 61755-062?
- 61755-062 is the product NDC for Otarmeni (lunsotogene parvec-cwha), Lunsotogene parvec 30000000000000 {GC}/mL injection, solution, listed with the FDA by Regeneron Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Otarmeni (Lunsotogene parvec-cwha).
- What is the active ingredient?
- Lunsotogene parvec.
- Who is the labeler?
- Regeneron Pharmaceuticals, Inc., NDC labeler code 61755. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Otarmeni?
- 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.