NDC codes

FDA NDC Directory
Product NDC (as listed)61755-062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61755-0062Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
61755-062-99617550062991 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

N461755006299 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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