oxaliplatin

In shortageOrange BookUNIISPLATC L01XA03

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

Identification

ManufacturerShandong New Time Pharmaceutical Co., Ltd.

CountryUS (United States)

ATC codeL01XA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4267733710
10 VIAL, SINGLE-DOSE in 1 CARTON (42677-337-10) / 20 mL in 1 VIAL, SINGLE-DOSE (42677-337-01)

Annotations

UNII (FDA Substance ID)

04ZR38536J

OXALIPLATIN

RxCUI 32592

Orange Book

A219765

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": "42677-337_4f6846af-385e-b624-e063-6394a90a28d7",
  "productndc": "42677-337",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219765",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 15, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/20ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 15, 2026"
      }
    ],
    "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": "ANDA219765",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxaliplatin",
  "start_marketing_date": "20260115",
  "active_numerator_strength": "5"
}

Related drugs

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