NDC 0591-2927

Levalbuterol tartrate HFA inhalation

Levalbuterol Tartrate

Levalbuterol tartrate HFA inhalation is a Oral Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Levalbuterol Tartrate.

Product ID0591-2927_47ae9104-0a80-4c9a-a2ed-24c8845bb333
NDC0591-2927
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol tartrate HFA inhalation
Generic NameLevalbuterol Tartrate
Dosage FormAerosol, Metered
Route of AdministrationORAL
Marketing Start Date2016-10-03
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021730
Labeler NameActavis Pharma, Inc.
Substance NameLEVALBUTEROL TARTRATE
Active Ingredient Strength45 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-2927-54

1 INHALER in 1 CARTON (0591-2927-54) > 200 AEROSOL, METERED in 1 INHALER
Marketing Start Date2016-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2927-54 [00591292754]

Levalbuterol tartrate HFA inhalation AEROSOL, METERED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021730
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-10-03

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL TARTRATE45 ug/1

OpenFDA Data

SPL SET ID:ac85703a-17a2-4f0b-87f4-78f1756d2f85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 745791
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Levalbuterol tartrate HFA inhalation" or generic name "Levalbuterol Tartrate"

    NDCBrand NameGeneric Name
    0591-2927Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    63187-876Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    63629-8822Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    68788-6845Levalbuterol tartrate HFA inhalationlevalbuterol tartrate
    63402-510Xopenex HFAlevalbuterol tartrate

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