NDC 70518-0526

levalbuterol hydrochloride

Levalbuterol Hydrochloride

levalbuterol hydrochloride is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Levalbuterol Hydrochloride.

Product ID70518-0526_504be875-0594-5871-e054-00144ff88e88
NDC70518-0526
Product TypeHuman Prescription Drug
Proprietary Namelevalbuterol hydrochloride
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2017-05-12
Marketing CategoryANDA / ANDA
Application NumberANDA077756
Labeler NameREMEDYREPACK INC.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0526-0

3 mL in 1 VIAL, SINGLE-DOSE (70518-0526-0)
Marketing Start Date2017-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0526-0 [70518052600]

levalbuterol hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA077756
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-12
Marketing End Date2020-04-06
Inactivation Date2020-01-31
Reactivation Date2020-04-06

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

OpenFDA Data

SPL SET ID:e7a29c3e-ff2d-49e5-ad9f-4d0feeafea0b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242754

    • Pharmacological Class

    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "levalbuterol hydrochloride" or generic name "Levalbuterol Hydrochloride"

    NDCBrand NameGeneric Name
    66993-021Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    66993-022Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    66993-023Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    70518-0526levalbuterol hydrochloridelevalbuterol hydrochloride
    76204-003Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    76204-002Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    0115-9930LevalbuterolLevalbuterol Hydrochloride
    0115-9931LevalbuterolLevalbuterol Hydrochloride
    0115-9932LevalbuterolLevalbuterol Hydrochloride
    35573-443LevalbuterolLevalbuterol Hydrochloride
    35573-444LevalbuterolLevalbuterol Hydrochloride
    35573-445LevalbuterolLevalbuterol Hydrochloride
    17478-171XopenexLevalbuterol Hydrochloride
    17478-172XopenexLevalbuterol Hydrochloride
    17478-173XopenexLevalbuterol Hydrochloride
    17478-174XopenexLevalbuterol Hydrochloride
    21695-153Xopenexlevalbuterol hydrochloride
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