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United States · US · US:25021-308_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b
esmolol hydrochloride
Orange BookUNIISPLATC C07AB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeC07AB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250213088410 BAG in 1 CARTON (25021-308-84) / 250 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A207107
APAP
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": "25021-308_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b",
"productndc": "25021-308",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207107",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/100ML",
"product_no": "001",
"approval_date": "Jun 8, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2GM/100ML",
"product_no": "002",
"approval_date": "Jun 8, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESMOLOL HYDROCHLORIDE",
"proprietary_name": "esmolol hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207107",
"marketing_category": "ANDA",
"nonproprietary_name": "esmolol hydrochloride",
"start_marketing_date": "20190715",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AB09.
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