NDC 0378-6993

Levalbuterol

Levalbuterol

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

Product ID0378-6993_0aa39730-fc51-4088-8955-b11aac3025d0
NDC0378-6993
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol
Dosage FormSolution, Concentrate
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2009-08-28
Marketing CategoryANDA / ANDA
Application NumberANDA078309
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/.5mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-6993-93

30 POUCH in 1 CARTON (0378-6993-93) > 1 VIAL in 1 POUCH (0378-6993-31) > .5 mL in 1 VIAL
Marketing Start Date2009-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6993-31 [00378699331]

Levalbuterol SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA078309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-28

NDC 0378-6993-93 [00378699393]

Levalbuterol SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA078309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-28

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/.5mL

OpenFDA Data

SPL SET ID:206bbdec-04f0-40e3-a259-32fc6bce20d8
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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