NDC 0093-4147

Levalbuterol

Levalbuterol

Levalbuterol is a Respiratory (inhalation) Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Levalbuterol Hydrochloride.

Product ID0093-4147_0921bb83-b7bf-4480-ba43-353484f501a7
NDC0093-4147
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol
Dosage FormSolution, Concentrate
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2014-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA200875
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/.5mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0093-4147-56

30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-4147-19 [00093414719]

Levalbuterol SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA200875
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-16

NDC 0093-4147-56 [00093414756]

Levalbuterol SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA200875
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-16

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/.5mL

OpenFDA Data

SPL SET ID:1b7537a3-409e-4d10-87db-302f05ce684e
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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