NDC 0378-9681

Levalbuterol

Levalbuterol

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

Product ID0378-9681_111e97b2-4366-4552-8bf8-c2f944fd317e
NDC0378-9681
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2013-03-15
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA077800
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-9681-44

2 POUCH in 1 CARTON (0378-9681-44) > 12 VIAL in 1 POUCH (0378-9681-96) > 3 mL in 1 VIAL
Marketing Start Date2013-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9681-96 [00378968196]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA077800
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-15
Marketing End Date2019-08-31

NDC 0378-9681-44 [00378968144]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA077800
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-15
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.63 mg/3mL

OpenFDA Data

SPL SET ID:322c7883-f01b-4ce9-b667-4924717a4e6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311286
  • 349590
  • 242754

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.