Temsirolimus

Orange BookSPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521920005
1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05)

Annotations

Orange Book

A207383

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a1f129ff-c0a4-ede7-ae9c-7a3cfa01fe12": {
      "match": "brand_token",
      "title": "TEMSIROLIMUS (TEMSIROLIMUS INJECTION) KIT [ALMAJECT, INC.]",
      "spl_version": "6",
      "published_date": "2025-12-18"
    }
  },
  "productid": "65219-200_2b33d5f1-198e-41ef-ac78-ccfd27fc137a",
  "productndc": "65219-200",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207383",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/ML (25MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Temsirolimus",
  "active_ingred_unit": null,
  "application_number": "ANDA207383",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Temsirolimus",
  "start_marketing_date": "20201120",
  "active_numerator_strength": null
}

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