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United States · US · US:70121-1037_f7911ddf-f082-4900-9504-d45cc15861c0
Argatroban
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121103711 VIAL, GLASS in 1 CARTON (70121-1037-1) / 2.5 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
A206698
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": "70121-1037_f7911ddf-f082-4900-9504-d45cc15861c0",
"productndc": "70121-1037",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206698",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/2.5ML (100MG/ML)",
"product_no": "001",
"approval_date": "Jan 26, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "Argatroban",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206698",
"marketing_category": "ANDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20180126",
"active_numerator_strength": "100"
}Related drugs
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