Oxaliplatin

In shortageOrange BookUNIISPLATC L01XA03

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeL01XA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808317001
10 mL in 1 VIAL (68083-170-01)

Annotations

UNII (FDA Substance ID)

04ZR38536J

OXALIPLATIN

RxCUI 32592

Orange Book

A207385

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": "68083-170_0d039035-85d1-40d4-8ee6-540026ab7a5c",
  "productndc": "68083-170",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207385",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "May 23, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "002",
        "approval_date": "May 23, 2017"
      }
    ],
    "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/10mL",
  "application_number": "ANDA207385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxaliplatin",
  "start_marketing_date": "20170529",
  "active_numerator_strength": "50"
}

Related drugs

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