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United States · US · US:55150-420_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
esmolol hydrochloride
Orange BookUNIISPLATC C07AB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeC07AB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551504201010 POUCH in 1 CARTON (55150-420-10) / 1 BAG in 1 POUCH (55150-420-01) / 250 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A216244
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": "55150-420_5aebd586-47c6-4e19-88e3-ef0ecb1cc875",
"productndc": "55150-420",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216244",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/100ML",
"product_no": "001",
"approval_date": "Mar 21, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2GM/100ML",
"product_no": "002",
"approval_date": "Mar 21, 2022"
}
],
"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": "ANDA216244",
"marketing_category": "ANDA",
"nonproprietary_name": "esmolol hydrochloride in sodium chloride",
"start_marketing_date": "20220321",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AB09.
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