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United States · US · US:72819-152_05e37cd7-f0c4-3bde-e063-6294a90a2acf

Mitomycin

Orange BookUNIISPLATC L01DC03

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

Identification

ManufacturerArchis Pharma LLC
CountryUS (United States)
ATC codeL01DC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7281915295
    1 VIAL in 1 CARTON (72819-152-95) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
50SG953SK6
MITOMYCIN
RxCUI 632
Orange Book
A202670
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "50SG953SK6",
    "rxcui": "632",
    "inchikey": "NWIBSHFKIJFRCO-WUDYKRTCSA-N",
    "display_name": "MITOMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5917f7a7-cd20-407b-8dda-9fd58c5f47a6": {
      "match": "brand_token",
      "title": "MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72819-152_05e37cd7-f0c4-3bde-e063-6294a90a2acf",
  "productndc": "72819-152",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202670",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 13, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/VIAL",
        "product_no": "002",
        "approval_date": "Oct 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MITOMYCIN",
  "proprietary_name": "Mitomycin",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA202670",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mitomycin",
  "start_marketing_date": "20220311",
  "active_numerator_strength": "5"
}

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