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United States · US · US:73554-3111_4a19a489-b94a-4a85-b094-0b6e9e3a6cd9

Zynteglo

UNIISPLATC B06AX02

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

Identification

ManufacturerGenetix Biotherapeutics Inc.
CountryUS (United States)
ATC codeB06AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7355431111
    1 SUSPENSION in 1 BAG (73554-3111-1)

Annotations

UNII (FDA Substance ID)
MEE8487RTP
BETIBEGLOGENE AUTOTEMCEL
RxCUI 2610349
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MEE8487RTP",
    "rxcui": "2610349",
    "inchikey": null,
    "display_name": "BETIBEGLOGENE AUTOTEMCEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "86931613-c262-47f5-8202-bc31fa69ad3d": {
      "match": "brand_token",
      "title": "ZYNTEGLO (BETIBEGLOGENE AUTOTEMCEL) SUSPENSION [GENETIX BIOTHERAPEUTICS INC.]",
      "spl_version": "6",
      "published_date": "2026-04-14"
    }
  },
  "productid": "73554-3111_4a19a489-b94a-4a85-b094-0b6e9e3a6cd9",
  "productndc": "73554-3111",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "CELLULAR THERAPY",
  "substance_name": "BETIBEGLOGENE AUTOTEMCEL",
  "proprietary_name": "Zynteglo",
  "active_ingred_unit": "1/1",
  "application_number": "BLA125717",
  "marketing_category": "BLA",
  "nonproprietary_name": "betibeglogene autotemcel",
  "start_marketing_date": "20220817",
  "active_numerator_strength": "20000000"
}

Related drugs

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