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United States · US · US:63323-104_d672a555-bb0e-4a82-ac5e-5c9393b59c28

Etoposide

Orange BookUNIISPLATC L01CB01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6332310405
    10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    6332310406
    1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    6332310425
    1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) / 25 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    6332310450
    1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50) / 50 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
6PLQ3CP4P3
ETOPOSIDE
RxCUI 4179
Orange Book
A074983
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6PLQ3CP4P3",
    "rxcui": "4179",
    "inchikey": "VJJPUSNTGOMMGY-MRVIYFEKSA-N",
    "display_name": "ETOPOSIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "7bc994df-ee84-4ed7-80fa-737f70918953": {
      "match": "brand_token",
      "title": "ETOPOSIDE CAPSULE [ONESOURCE SPECIALTY PHARMA LIMITED]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "63323-104_d672a555-bb0e-4a82-ac5e-5c9393b59c28",
  "productndc": "63323-104",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "074983",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Sep 30, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETOPOSIDE",
  "proprietary_name": "Etoposide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA074983",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ETOPOSIDE",
  "start_marketing_date": "20010718",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code L01CB01.

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