🇺🇸
United States · US · US:65219-429_c650fddc-9627-4dc0-af04-8a7d6e423da9
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165219429501 VIAL in 1 CARTON (65219-429-50) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
A214235
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "IY90U61Z3S",
"rxcui": "15202",
"inchikey": "AIEZTKLTLCMZIA-CZSXTPSTSA-N",
"display_name": "ARGATROBAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"b0dedf95-8395-46bf-b94a-dcf2dd085942": {
"match": "brand_token",
"title": "ARGATROBAN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
"spl_version": "6",
"published_date": "2026-05-25"
}
},
"productid": "65219-429_c650fddc-9627-4dc0-af04-8a7d6e423da9",
"productndc": "65219-429",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214235",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/50ML (1MG/ML)",
"product_no": "001",
"approval_date": "Jan 21, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/50mL",
"application_number": "ANDA214235",
"marketing_category": "ANDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20210524",
"active_numerator_strength": "50"
}Related drugs
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