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United States · US · US:67457-658_4fdea9d3-714d-4d54-9c23-bde0edd85b59
esmolol hydrochloride in sodium chloride
Orange BookUNIISPLATC C07AB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeC07AB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457658101 BAG in 1 POUCH (67457-658-10) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A206608
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": "67457-658_4fdea9d3-714d-4d54-9c23-bde0edd85b59",
"productndc": "67457-658",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "206608",
"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 in sodium chloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206608",
"marketing_category": "ANDA",
"nonproprietary_name": "esmolol hydrochloride in sodium chloride",
"start_marketing_date": "20180904",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C07AB09.
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