oxaliplatin

In shortageOrange BookUNIISPLATC L01XA03

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeL01XA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1672933203
1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-03) / 10 mL in 1 VIAL, SINGLE-DOSE
ndc11
1672933205
1 VIAL, SINGLE-DOSE in 1 CARTON (16729-332-05) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

04ZR38536J

OXALIPLATIN

RxCUI 32592

Orange Book

A207474

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": "16729-332_0e2ec613-5375-858e-e063-6294a90ab95a",
  "productndc": "16729-332",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "207474",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/20ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG/40ML (5MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 21, 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/mL",
  "application_number": "ANDA207474",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxaliplatin",
  "start_marketing_date": "20180517",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code L01XA03.

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