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United States · US · US:70121-1717_9fb24e34-22d9-43e6-b611-39e17092e76f
Esmolol Hydrochloride
Orange BookUNIISPLATC C07AB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC07AB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11701211717312 POUCH in 1 CARTON (70121-1717-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
- ndc11701211717710 POUCH in 1 CARTON (70121-1717-7) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A216603
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": "70121-1717_9fb24e34-22d9-43e6-b611-39e17092e76f",
"productndc": "70121-1717",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216603",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/100ML",
"product_no": "001",
"approval_date": "Dec 13, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2GM/100ML",
"product_no": "002",
"approval_date": "Dec 13, 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": "ANDA216603",
"marketing_category": "ANDA",
"nonproprietary_name": "Esmolol Hydrochloride in Sodium Chloride",
"start_marketing_date": "20221216",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C07AB09.
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