Otarmeni Injection, Solution
NDC Package 61755-062-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Otarmeni (lunsotogene parvec) injection is 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)]. This formulation utilizes a injection, solution delivery system. Marketed by Regeneron Pharmaceuticals, Inc., this product is identified by NDC 61755-062 and is authorized under FDA application BLA125874.

Identification & Billing

NDC Package Code
61755-062-99
Package Description
1 CARTON in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-062-01) / 1 mL in 1 VIAL, SINGLE-DOSE (61755-062-00)
Product Code
61755-062
11-Digit Billing Format
61755006299
RxNorm Crosswalk
  • RxCUI: 2741622 - lunsotogene parvec-cwha 3.0 x 10(13) vg/ML in 0.63 ML Injection
  • RxCUI: 2741622 - 0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection
  • RxCUI: 2741622 - lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES per 0.63 ML Injection
  • RxCUI: 2741629 - Otarmeni 3.0 x 10(13) vg/ML in 0.63 ML Injection
  • RxCUI: 2741629 - 0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection [Otarmeni]

Clinical Specifications

Proprietary Name
Otarmeni
Non-Proprietary Name
Lunsotogene Parvec
Substance Name
Lunsotogene Parvec 3' Vector
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
LUNSOTOGENE PARVEC 3' VECTOR 30000000000000 {GC}/mL
Usage Information
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 UseOTARMENI is not recommended in patients in whom preoperative imaging demonstrates that access to the inner ear is not feasible including those with abnormal mastoid pneumatization or clinically significant anatomic variations of the middle ear and inner ear.

Regulatory & Marketing

Labeler Name
Regeneron Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125874
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-23-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61755-062-99 identifies a specific commercial package of 1 carton in 1 bag / 1 vial, single-dose in 1 carton (61755-062-01) / 1 ml in 1 vial, single-dose (61755-062-00) of Otarmeni, a human prescription drug labeled by Regeneron Pharmaceuticals, Inc.. This injection, solution is formulated for intracochlear use and contains lunsotogene parvec 3' vector as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Regeneron Pharmaceuticals, Inc. on April 23, 2026. The current certification is valid through December 31, 2027.

How is this Regeneron Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61755006299. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61755-062-99
11-Digit CMS (5-4-2)
61755-0062-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.