NDC 65862-945

Levalbuterol

Levalbuterol

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

Product ID65862-945_42009cec-142c-4d6b-9b09-0d12b2e6b65d
NDC65862-945
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2016-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA207625
Labeler NameAurobindo Pharma Limited
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 65862-945-24

2 POUCH in 1 CARTON (65862-945-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-945-12) > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2016-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-945-24 [65862094524]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA207625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-30

NDC 65862-945-12 [65862094512]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA207625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-30

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

OpenFDA Data

SPL SET ID:5f1c4f22-d420-495c-8f64-33532638215f
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
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