NDC 0093-4146

Levalbuterol

Levalbuterol

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

Product ID0093-4146_43e2d0a6-b135-41c9-b92c-abdc008041ae
NDC0093-4146
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2013-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA090297
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-4146-56

6 POUCH in 1 CARTON (0093-4146-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-4146-04 [00093414604]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA090297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-04-29

NDC 0093-4146-64 [00093414664]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA090297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-04-29
Marketing End Date2019-12-31

NDC 0093-4146-56 [00093414656]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA090297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-07

NDC 0093-4146-45 [00093414645]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA090297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-04

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.63 mg/3mL

OpenFDA Data

SPL SET ID:f3ce78d9-e923-400e-b3cd-3e6124ac7f6d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311286
  • 349590
  • 242754
    • UPC Code
  • 0300934145564
  • 0300934146561
  • 0300934148565

    • Pharmacological Class

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