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United States · US · US:39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95

dactinomycin

Orange BookUNIISPLATC L01DA01

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeL01DA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3982221002
    1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)

Annotations

UNII (FDA Substance ID)
1CC1JFE158
DACTINOMYCIN
RxCUI 3100
Orange Book
A203999
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1CC1JFE158",
    "rxcui": "3100",
    "inchikey": "RJURFGZVJUQBHK-IIXSONLDSA-N",
    "display_name": "DACTINOMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5da55538-2602-4704-a9da-603c9f7ff7dc": {
      "match": "brand_token",
      "title": "DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]",
      "spl_version": "2",
      "published_date": "2024-06-19"
    }
  },
  "productid": "39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95",
  "productndc": "39822-2100",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "203999",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.5MG/VIAL",
        "product_no": "001",
        "approval_date": "May 20, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DACTINOMYCIN",
  "proprietary_name": "dactinomycin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203999",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dactinomycin",
  "start_marketing_date": "20190731",
  "active_numerator_strength": ".5"
}

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