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United States · US · US:73650-316_a43c4966-e649-4105-b439-eea5232c94f2

TZIELD

UNIISPLATC A10XX01

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

Identification

ManufacturerProvention Bio, Inc.
CountryUS (United States)
ATC codeA10XX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7365031601
    1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
S4M959U2IJ
TEPLIZUMAB
RxCUI 2621880
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S4M959U2IJ",
    "rxcui": "2621880",
    "inchikey": null,
    "display_name": "TEPLIZUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e8a39a5f-139c-4510-9777-71cbb00138fa": {
      "match": "brand_token",
      "title": "TZIELD (TEPLIZUMAB-MZWV) INJECTION [PROVENTION BIO, INC.]",
      "spl_version": "6",
      "published_date": "2026-04-23"
    }
  },
  "productid": "73650-316_a43c4966-e649-4105-b439-eea5232c94f2",
  "productndc": "73650-316",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEPLIZUMAB",
  "proprietary_name": "TZIELD",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761183",
  "marketing_category": "BLA",
  "nonproprietary_name": "teplizumab-mzwv",
  "start_marketing_date": "20221117",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A10XX01.

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