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United States · US · US:61703-363_ecdfccf3-58e8-47ce-89d3-53a4d3e3af21

Oxaliplatin

In shortageOrange BookUNIISPLATC L01XA03

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeL01XA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6170336318
    1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18) / 10 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6170336322
    1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
04ZR38536J
OXALIPLATIN
RxCUI 32592
Orange Book
A078813
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Oxaliplatin Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "04ZR38536J",
    "rxcui": "32592",
    "inchikey": "ZROHGHOFXNOHSO-BNTLRKBRSA-L",
    "display_name": "OXALIPLATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1ac38523-480b-4c0f-97a1-7dfa1432923c": {
      "match": "brand_token",
      "title": "OXALIPLATIN INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]",
      "spl_version": "2",
      "published_date": "2026-04-15"
    }
  },
  "productid": "61703-363_ecdfccf3-58e8-47ce-89d3-53a4d3e3af21",
  "productndc": "61703-363",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "078813",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 7, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/20ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Aug 7, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXALIPLATIN",
  "shortage_reason": "Oxaliplatin Injection",
  "shortage_status": "current",
  "proprietary_name": "Oxaliplatin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078813",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXALIPLATIN",
  "start_marketing_date": "20090810",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code L01XA03.

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