NDC 0115-9930

Levalbuterol

Levalbuterol Hydrochloride

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

Product ID0115-9930_47aabe93-95d8-4181-aa97-1223ebb07e29
NDC0115-9930
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA203653
Labeler NameImpax Generics
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength0 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0115-9930-78

1 POUCH in 1 CARTON (0115-9930-78) > 25 AMPULE in 1 POUCH (0115-9930-76) > 3 mL in 1 AMPULE
Marketing Start Date2017-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-9930-78 [00115993078]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA203653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-02-17

NDC 0115-9930-76 [00115993076]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA203653
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-22

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.31 mg/3mL

OpenFDA Data

SPL SET ID:e5c8368a-49f9-45cf-9d42-a871f005edb9
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 Hydrochloride"

    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
    68788-6777LevalbuterolLevalbuterol
    76204-900LevalbuterolLevalbuterol
    76204-800LevalbuterolLevalbuterol
    76204-700LevalbuterolLevalbuterol
    63187-953LevalbuterolLevalbuterol
    65862-944LevalbuterolLevalbuterol
    65862-942LEVALBUTEROLLEVALBUTEROL
    65862-945LevalbuterolLevalbuterol
    65862-943LevalbuterolLevalbuterol
    68071-5027LevalbuterolLevalbuterol
    68071-2340LevalbuterolLevalbuterol
    17478-171XopenexLevalbuterol Hydrochloride
    17478-172XopenexLevalbuterol Hydrochloride
    17478-173XopenexLevalbuterol Hydrochloride
    17478-174XopenexLevalbuterol Hydrochloride
    21695-153Xopenexlevalbuterol hydrochloride
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