FDA.reportPublic FDA data

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
IngredientStrength
LUNSOTOGENE PARVEC30000000000000 {GC}/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P6ZNU67HPUInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7a5e936-ab4a-4609-ac10-96efedc89035Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61755-062-00OTARMENI1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
61755-062-01OTARMENI1 in 1 CARTONINJECTION, SOLUTION14
61755-062-99OTARMENI1 in 1 BAGINJECTION, SOLUTION14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OTARMENILUNSOTOGENE PARVEC-CWHARegeneron Pharmaceuticals, Inc.a7a5e936-ab4a-4609-ac10-96efedc890352026-04-27Warnings, Adverse reactionsExact identifier
application number: BLA125874
ndc (product): 61755-062

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125874OTARMENIlunsotogene parvec-cwha351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741622lunsotogene parvec-cwha 3.0 x 10(13) vg/ML in 0.63 ML InjectionPSNa7a5e936-ab4a-4609-ac10-96efedc890354
2741629Otarmeni 3.0 x 10(13) vg/ML in 0.63 ML InjectionPSNa7a5e936-ab4a-4609-ac10-96efedc890354
27416290.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection [Otarmeni]SBDa7a5e936-ab4a-4609-ac10-96efedc890354
27416220.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML InjectionSCDa7a5e936-ab4a-4609-ac10-96efedc890354
2741622lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES per 0.63 ML InjectionSYa7a5e936-ab4a-4609-ac10-96efedc890354
2741629Otarmeni 30000000000000 VECTOR-GENOMES per 0.63 ML InjectionSYa7a5e936-ab4a-4609-ac10-96efedc890354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61755-062-00617550062001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
61755-062-01617550062011 in 1 CARTONHistorical
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) 1 carton2026-04-23NoNoCurrent