NDC 65862-942

LEVALBUTEROL

Levalbuterol

LEVALBUTEROL is a Respiratory (inhalation) Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Levalbuterol Hydrochloride.

Product ID65862-942_931c6a51-bf5b-4052-969c-239015418e93
NDC65862-942
Product TypeHuman Prescription Drug
Proprietary NameLEVALBUTEROL
Generic NameLevalbuterol
Dosage FormSolution, Concentrate
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2017-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA207628
Labeler NameAurobindo Pharma Limited
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/.5mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65862-942-03

30 POUCH in 1 CARTON (65862-942-03) > 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) > .5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-942-03 [65862094203]

LEVALBUTEROL SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA207628
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-31

NDC 65862-942-50 [65862094250]

LEVALBUTEROL SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA207628
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-31

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/.5mL

OpenFDA Data

SPL SET ID:e1a9effb-6ef7-4651-b0ef-a9265600caff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1855389

    • Pharmacological Class

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

    NDC Crossover Matching brand name "LEVALBUTEROL" or generic name "Levalbuterol"

    NDCBrand NameGeneric Name
    0093-4145LevalbuterolLevalbuterol
    0093-4146LevalbuterolLevalbuterol
    0093-4147LevalbuterolLevalbuterol
    0093-4148LevalbuterolLevalbuterol
    0115-9930LevalbuterolLevalbuterol Hydrochloride
    0115-9931LevalbuterolLevalbuterol Hydrochloride
    0115-9932LevalbuterolLevalbuterol Hydrochloride
    0378-6993Levalbuterollevalbuterol
    0378-9680Levalbuterollevalbuterol
    0378-9681Levalbuterollevalbuterol
    0378-9682Levalbuterollevalbuterol
    0378-9690LevalbuterolLevalbuterol
    0378-9691LevalbuterolLevalbuterol
    0378-9692LevalbuterolLevalbuterol
    35573-443LevalbuterolLevalbuterol Hydrochloride
    35573-444LevalbuterolLevalbuterol Hydrochloride
    35573-445LevalbuterolLevalbuterol Hydrochloride
    63187-953LevalbuterolLevalbuterol
    65862-942LEVALBUTEROLLEVALBUTEROL
    65862-943LevalbuterolLevalbuterol
    65862-944LevalbuterolLevalbuterol
    65862-945LevalbuterolLevalbuterol
    68788-6777LevalbuterolLevalbuterol
    76204-900LevalbuterolLevalbuterol
    76204-800LevalbuterolLevalbuterol
    76204-700LevalbuterolLevalbuterol
    68071-5027LevalbuterolLevalbuterol
    68071-2340LevalbuterolLevalbuterol
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