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United States · US · US:55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1155150241011 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE
- ndc11551502411010 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
N209552
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": "55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0",
"productndc": "55150-241",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "209552",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG/50ML (1MG/ML)",
"product_no": "001",
"approval_date": "Nov 27, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/50mL",
"application_number": "NDA209552",
"marketing_category": "NDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20181127",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code B01AE03.
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