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United States · US · US:61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58

ETOPOPHOS

Orange BookUNIISPLATC L01CB01

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

Identification

ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeL01CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6126941020
    1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
528XYJ8L1N
ETOPOSIDE PHOSPHATE
RxCUI 24614
Orange Book
N020457
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "528XYJ8L1N",
    "rxcui": "24614",
    "inchikey": "LIQODXNTTZAGID-OCBXBXKTSA-N",
    "display_name": "ETOPOSIDE PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "7499fc35-fae8-44ad-bbab-9a1a589bf3ee": {
      "match": "brand_token",
      "title": "ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [H2-PHARMA, LLC]",
      "spl_version": "22",
      "published_date": "2025-11-26"
    }
  },
  "productid": "61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58",
  "productndc": "61269-410",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020457",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 17, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETOPOSIDE PHOSPHATE",
  "proprietary_name": "ETOPOPHOS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020457",
  "marketing_category": "NDA",
  "nonproprietary_name": "etoposide phosphate",
  "start_marketing_date": "20090601",
  "active_numerator_strength": "100"
}

Related drugs

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