🇺🇸
United States · US · US:68083-141_c07a92fe-93d4-456d-8df2-ce14959116b6
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083141022 VIAL in 1 CARTON (68083-141-02) / 125 mL in 1 VIAL (68083-141-01)
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
A205570
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": "68083-141_c07a92fe-93d4-456d-8df2-ce14959116b6",
"productndc": "68083-141",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205570",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "125MG/125ML (1MG/ML)",
"product_no": "001",
"approval_date": "May 22, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/125mL",
"application_number": "ANDA205570",
"marketing_category": "ANDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20170526",
"active_numerator_strength": "125"
}Related drugs
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