🇺🇸
United States · US · US:0143-9559_9d3d08d4-ce59-49e2-b8be-0ac1204e33e5
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101439559011 VIAL in 1 CARTON (0143-9559-01) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
N203049
APAP
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": "0143-9559_9d3d08d4-ce59-49e2-b8be-0ac1204e33e5",
"productndc": "0143-9559",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "203049",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "250MG/2.5ML (100MG/ML)",
"product_no": "001",
"approval_date": "Jan 5, 2012"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "50MG/50ML (1MG/ML)",
"product_no": "002",
"approval_date": "Sep 30, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/50mL",
"application_number": "NDA203049",
"marketing_category": "NDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20161101",
"active_numerator_strength": "50"
}Related drugs
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