Temsirolimus

Orange BookSPL

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672922361
1 KIT in 1 KIT (16729-223-61) * 1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30) * 1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30)

Annotations

Orange Book

A203153

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "16729-223_116814b6-e438-8a45-e063-6394a90a9fad",
  "productndc": "16729-223",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203153",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/ML (25MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 30, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Temsirolimus",
  "active_ingred_unit": null,
  "application_number": "ANDA203153",
  "marketing_category": "ANDA",
  "nonproprietary_name": "temsirolimus",
  "start_marketing_date": "20180813",
  "active_numerator_strength": null
}

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