Oxaliplatin

In shortageOrange BookUNIISPLATC L01XA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeL01XA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0781931780
1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80) / 20 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

04ZR38536J

OXALIPLATIN

RxCUI 32592

Orange Book

A078817

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": "0781-9317_ac83b4cd-5026-4dd5-b733-125d28ba3c95",
  "productndc": "0781-9317",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078817",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 24, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/20ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 24, 2011"
      }
    ],
    "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": "ANDA078817",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxaliplatin",
  "start_marketing_date": "20160701",
  "active_numerator_strength": "5"
}

Related drugs

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