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United States · US · US:83301-0062_8b45a05d-47a6-4a64-b232-108bd7185eba
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMullan Pharmaceutical Inc.
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183301006211 VIAL, SINGLE-DOSE in 1 CARTON (83301-0062-1) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
A217848
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": "83301-0062_8b45a05d-47a6-4a64-b232-108bd7185eba",
"productndc": "83301-0062",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "217848",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/50ML (1MG/ML)",
"product_no": "001",
"approval_date": "Jul 31, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/50mL",
"application_number": "ANDA217848",
"marketing_category": "ANDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20260101",
"active_numerator_strength": "50"
}Related drugs
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