🇺🇸
United States · US · US:16729-430_525900ef-aa6b-7f43-e063-6294a90a27de
ARGATROBAN
Orange BookUNIISPLATC B01AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeB01AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116729430111 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE
- ndc11167294304310 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
N212035
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": "16729-430_525900ef-aa6b-7f43-e063-6294a90a27de",
"productndc": "16729-430",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "212035",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/50ML (1MG/ML)",
"product_no": "001",
"approval_date": "Jun 7, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARGATROBAN",
"proprietary_name": "ARGATROBAN",
"active_ingred_unit": "mg/mL",
"application_number": "NDA212035",
"marketing_category": "NDA",
"nonproprietary_name": "Argatroban",
"start_marketing_date": "20211007",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code B01AE03.
- NLArganova Multidose 100 mg/ml concentraat voor oplossing voor infusieEthypharm
- NLArganova Multidose 100mg/ml concentraat voor oplossing voor infusieBModesto B.V.
- 🇺🇸ArgatrobanHikma Pharmaceuticals USA Inc.
- 🇺🇸ArgatrobanFresenius Kabi USA, LLC
- 🇺🇸ArgatrobanAmneal Pharmaceuticals LLC
- 🇺🇸ArgatrobanEugia US LLC
- 🇺🇸ArgatrobanHikma Pharmaceuticals USA Inc.
- 🇺🇸ArgatrobanMullan Pharmaceutical Inc.
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