LYMPHIR

UNIISPLATC L01XX29

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

Identification

ManufacturerCitius Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01XX29

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5265877771
1 VIAL, SINGLE-DOSE in 1 CARTON (52658-7777-1) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

25E79B5CTM

DENILEUKIN DIFTITOX

RxCUI 214470

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "25E79B5CTM",
    "rxcui": "214470",
    "inchikey": null,
    "display_name": "DENILEUKIN DIFTITOX",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ac3613d7-4304-40e7-a3f5-adb8a8adca5d": {
      "match": "brand_token",
      "title": "LYMPHIR (DENILEUKIN DIFTITOX-CXDL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CITIUS PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2025-03-03"
    }
  },
  "productid": "52658-7777_2c678496-2a12-3051-e063-6294a90a205e",
  "productndc": "52658-7777",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DENILEUKIN DIFTITOX",
  "proprietary_name": "LYMPHIR",
  "active_ingred_unit": "ug/2mL",
  "application_number": "BLA761312",
  "marketing_category": "BLA",
  "nonproprietary_name": "denileukin diftitox-cxdl",
  "start_marketing_date": "20250301",
  "active_numerator_strength": "300"
}

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