NDC 68071-5027

Levalbuterol

Levalbuterol Hydrochloride

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

Product ID68071-5027_9016634a-1be1-700d-e053-2995a90a8f27
NDC68071-5027
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 NameNuCare Pharmaceuticals,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 68071-5027-5

3 mL in 1 AMPULE (68071-5027-5)
Marketing Start Date2019-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-5027-5 [68071502705]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA203653
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-14

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

OpenFDA Data

SPL SET ID:901679b1-ba77-0ed7-e053-2a95a90a6520
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242754
  • UPC Code
  • 0368071502756
  • 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 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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