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United States · US · US:44567-812_0aee9e81-c563-4207-9157-8bf70a163010
Esmolol Hydrochloride in Water
Orange BookUNIISPLATC C07AB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeC07AB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11445678121010 BAG in 1 CARTON (44567-812-10) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
N205703
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V05260LC8D",
"rxcui": "203222",
"inchikey": "GEKNCWBANDDJJL-UHFFFAOYSA-N",
"display_name": "ESMOLOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f0a56c07-8f0f-4499-8d00-f13a966bf988": {
"match": "brand_token",
"title": "ESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]",
"spl_version": "15",
"published_date": "2026-05-21"
}
},
"productid": "44567-812_0aee9e81-c563-4207-9157-8bf70a163010",
"productndc": "44567-812",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "205703",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.5GM/250ML (10MG/ML)",
"product_no": "001",
"approval_date": "Apr 7, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2GM/100ML (20MG/ML)",
"product_no": "002",
"approval_date": "Apr 7, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESMOLOL HYDROCHLORIDE",
"proprietary_name": "Esmolol Hydrochloride in Water",
"active_ingred_unit": "mg/mL",
"application_number": "NDA205703",
"marketing_category": "NDA",
"nonproprietary_name": "Esmolol Hydrochloride",
"start_marketing_date": "20171204",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C07AB09.
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