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United States · US · US:67457-212_08b6fbe4-ad4f-45eb-aad5-0b6bac026652
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457212021 VIAL, GLASS in 1 CARTON (67457-212-02) / 2.5 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
A202626
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": "67457-212_08b6fbe4-ad4f-45eb-aad5-0b6bac026652",
"productndc": "67457-212",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "202626",
"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": "ANDA202626",
"marketing_category": "ANDA",
"nonproprietary_name": "argatroban",
"start_marketing_date": "20171114",
"active_numerator_strength": "250"
}Related drugs
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