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United States · US · US:63323-750_504bf43e-4c28-4375-a6f4-285b2357f7f7
Oxaliplatin
In shortageOrange BookUNIISPLATC L01XA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01XA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
04ZR38536J
OXALIPLATIN
RxCUI 32592
Orange Book
A078811
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": "63323-750_504bf43e-4c28-4375-a6f4-285b2357f7f7",
"productndc": "63323-750",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "078811",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/10ML (5MG/ML)",
"product_no": "001",
"approval_date": "Jun 10, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/20ML (5MG/ML)",
"product_no": "002",
"approval_date": "Jun 10, 2010"
}
],
"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": "ANDA078811",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxaliplatin",
"start_marketing_date": "20100611",
"active_numerator_strength": "5"
}Related drugs
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