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United States · US · US:42023-182_369ba938-a680-4b30-9377-e997614d5fee
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142023182011 VIAL in 1 CARTON (42023-182-01) / 2.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
A091665
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": "42023-182_369ba938-a680-4b30-9377-e997614d5fee",
"productndc": "42023-182",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "091665",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/2.5ML (100MG/ML)",
"product_no": "001",
"approval_date": "Jun 30, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/2.5mL",
"application_number": "ANDA091665",
"marketing_category": "ANDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20150601",
"active_numerator_strength": "250"
}Related drugs
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