UNLOXCYT

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7009513001
1 VIAL, GLASS in 1 CARTON (70095-130-01) / 5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

PNW7GBB44P

COSIBELIMAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "PNW7GBB44P",
    "rxcui": null,
    "inchikey": null,
    "display_name": "COSIBELIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "06bdadd5-d2db-406f-a3f8-de47f48a52e3": {
      "match": "brand_token",
      "title": "UNLOXCYT (COSIBELIMAB) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "3",
      "published_date": "2025-12-09"
    }
  },
  "productid": "70095-130_32956dbc-6fe7-4e40-8496-cead92e453b7",
  "productndc": "70095-130",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COSIBELIMAB",
  "proprietary_name": "UNLOXCYT",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA761297",
  "marketing_category": "BLA",
  "nonproprietary_name": "cosibelimab",
  "start_marketing_date": "20251208",
  "active_numerator_strength": "300"
}

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