Home NDC 61755-062 OTARMENI
Product NDC 61755-062
11-digit product format 617550062
Labeler code 61755
Product ID 61755-062_f878e432-ce74-4536-942e-fb12bbb2c004
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lunsotogene parvec
Dosage form INJECTION, SOLUTION
Route INTRACOCHLEAR
Labeler Regeneron Pharmaceuticals, Inc.
Application BLA125874
Marketing category BLA
Marketing start 2026-04-23
Substance LUNSOTOGENE PARVEC 3' VECTOR
Active strength 30000000000000 {GC}/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base OTARMENI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUNSOTOGENE PARVEC 3' VECTOR 30000000000000 {GC}/mL
Harmonized Identifiers# Field, Values table Field Values Unii PA2E3JN26W Rxcui 2741622, 2741629
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61755-062-00 OTARMENI 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 4 61755-062-01 OTARMENI 1 in 1 CARTON INJECTION, SOLUTION 1 4 61755-062-99 OTARMENI 1 in 1 BAG INJECTION, SOLUTION 1 4
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61755-062-00 61755006200 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 61755-062-01 61755006201 1 in 1 CARTON Historical 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) 1 carton 2026-04-23 No No Current