🇺🇸
United States · US · US:63323-526_c5ad8f27-49b3-41a1-884f-4e07ffa86558
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 · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
N201811
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": "63323-526_c5ad8f27-49b3-41a1-884f-4e07ffa86558",
"productndc": "63323-526",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "201811",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG/2.5ML (100MG/ML)",
"product_no": "001",
"approval_date": "Mar 23, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/mL",
"application_number": "NDA201811",
"marketing_category": "NDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20150323",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code B01AE03.
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- 🇺🇸ArgatrobanHikma Pharmaceuticals USA Inc.
- 🇺🇸ArgatrobanFresenius Kabi USA, LLC
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