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United States · US · US:61755-062_f878e432-ce74-4536-942e-fb12bbb2c004

OTARMENI

UNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRegeneron Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6175506299
    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)

Annotations

UNII (FDA Substance ID)
PA2E3JN26W
LUNSOTOGENE PARVEC 3' VECTOR
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "PA2E3JN26W",
    "rxcui": null,
    "inchikey": null,
    "display_name": "LUNSOTOGENE PARVEC 3' VECTOR",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRACOCHLEAR",
  "spl_meta": {
    "a7a5e936-ab4a-4609-ac10-96efedc89035": {
      "match": "brand_token",
      "title": "OTARMENI (LUNSOTOGENE PARVEC) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2026-05-01"
    }
  },
  "productid": "61755-062_f878e432-ce74-4536-942e-fb12bbb2c004",
  "productndc": "61755-062",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LUNSOTOGENE PARVEC 3' VECTOR",
  "proprietary_name": "OTARMENI",
  "active_ingred_unit": "{GC}/mL",
  "application_number": "BLA125874",
  "marketing_category": "BLA",
  "nonproprietary_name": "lunsotogene parvec",
  "start_marketing_date": "20260423",
  "active_numerator_strength": "30000000000000"
}

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