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United States · US · US:68083-163_89007399-3c34-40d2-8068-a0b8e09cbef8
CISPLATIN
Orange BookUNIISPLATC L01XA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01XA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083163011 VIAL in 1 CARTON (68083-163-01) / 100 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
Q20Q21Q62J
CISPLATIN
RxCUI 2555
Orange Book
A207323
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q20Q21Q62J",
"rxcui": "2555",
"inchikey": "LXZZYRPGZAFOLE-UHFFFAOYSA-L",
"display_name": "CISPLATIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"76aea034-6d58-4390-a164-36aa09c1f101": {
"match": "brand_token",
"title": "CISPLATIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
"spl_version": "3",
"published_date": "2025-11-20"
}
},
"productid": "68083-163_89007399-3c34-40d2-8068-a0b8e09cbef8",
"productndc": "68083-163",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207323",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Mar 17, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CISPLATIN",
"proprietary_name": "CISPLATIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207323",
"marketing_category": "ANDA",
"nonproprietary_name": "Cisplatin",
"start_marketing_date": "20170403",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01XA01.
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