NDC 76204-003

Levalbuterol Hydrochloride

Levalbuterol Hydrochloride

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

Product ID76204-003_f54c79f2-308f-4c04-8a6f-186fbc90bb8c
NDC76204-003
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol Hydrochloride
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2012-12-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020837
Labeler NameRitedose Pharmaceuticals, LLC
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength1 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 76204-003-24

2 POUCH in 1 CARTON (76204-003-24) > 12 AMPULE in 1 POUCH > 3 mL in 1 AMPULE
Marketing Start Date2012-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76204-003-24 [76204000324]

Levalbuterol Hydrochloride SOLUTION
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-12-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

OpenFDA Data

SPL SET ID:6925ab5e-4f50-4d04-b55a-8a6f74474382
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311286
  • 242754

    • Pharmacological Class

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

    Medicade Reported Pricing

    76204000324 LEVALBUTEROL 1.25 MG/3 ML SOL

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Levalbuterol Hydrochloride" or generic name "Levalbuterol Hydrochloride"

    NDCBrand NameGeneric Name
    66993-021Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    66993-022Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    66993-023Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    70518-0526levalbuterol hydrochloridelevalbuterol hydrochloride
    76204-003Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    76204-002Levalbuterol HydrochlorideLevalbuterol Hydrochloride
    0115-9930LevalbuterolLevalbuterol Hydrochloride
    0115-9931LevalbuterolLevalbuterol Hydrochloride
    0115-9932LevalbuterolLevalbuterol Hydrochloride
    35573-443LevalbuterolLevalbuterol Hydrochloride
    35573-444LevalbuterolLevalbuterol Hydrochloride
    35573-445LevalbuterolLevalbuterol Hydrochloride
    17478-171XopenexLevalbuterol Hydrochloride
    17478-172XopenexLevalbuterol Hydrochloride
    17478-173XopenexLevalbuterol Hydrochloride
    17478-174XopenexLevalbuterol Hydrochloride
    21695-153Xopenexlevalbuterol hydrochloride
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