NDC 67457-658

esmolol hydrochloride in sodium chloride

Esmolol Hydrochloride In Sodium Chloride

esmolol hydrochloride in sodium chloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Esmolol Hydrochloride.

Product ID67457-658_08eb56ec-0d17-45a5-a0a9-9741b1d14909
NDC67457-658
Product TypeHuman Prescription Drug
Proprietary Nameesmolol hydrochloride in sodium chloride
Generic NameEsmolol Hydrochloride In Sodium Chloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-04
Marketing CategoryANDA / ANDA
Application NumberANDA206608
Labeler NameMylan Institutional LLC
Substance NameESMOLOL HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-658-10

1 BAG in 1 POUCH (67457-658-10) > 100 mL in 1 BAG
Marketing Start Date2018-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-658-10 [67457065810]

esmolol hydrochloride in sodium chloride INJECTION
Marketing CategoryANDA
Application NumberANDA206608
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-04

Drug Details

Active Ingredients

IngredientStrength
ESMOLOL HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:01ad7942-99c3-40ee-9cfb-272fb6c44e2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 979432
  • 1736541

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "esmolol hydrochloride in sodium chloride" or generic name "Esmolol Hydrochloride In Sodium Chloride"

    NDCBrand NameGeneric Name
    67457-657esmolol hydrochloride in sodium chlorideesmolol hydrochloride in sodium chloride
    67457-658esmolol hydrochloride in sodium chlorideesmolol hydrochloride in sodium chloride
    55150-420esmolol hydrochlorideesmolol hydrochloride in sodium chloride
    55150-421esmolol hydrochlorideesmolol hydrochloride in sodium chloride
    70121-1716Esmolol HydrochlorideEsmolol Hydrochloride in Sodium Chloride
    70121-1717Esmolol HydrochlorideEsmolol Hydrochloride in Sodium Chloride
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