NDC 53002-1750

ProAir RespiClick

Albuterol Sulfate

ProAir RespiClick is a Respiratory (inhalation) Powder, Metered in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Albuterol Sulfate.

Product ID53002-1750_740a54b2-fc44-48b5-87ba-3073f6a1cf9b
NDC53002-1750
Product TypeHuman Prescription Drug
Proprietary NameProAir RespiClick
Generic NameAlbuterol Sulfate
Dosage FormPowder, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2015-04-23
Marketing CategoryNDA / NDA
Application NumberNDA205636
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameALBUTEROL SULFATE
Active Ingredient Strength90 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-1750-1

1 INHALER in 1 BOX (53002-1750-1) > 200 POWDER, METERED in 1 INHALER
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1750-1 [53002175001]

ProAir RespiClick POWDER, METERED
Marketing CategoryNDA
Application NumberNDA205636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE90 ug/1

OpenFDA Data

SPL SET ID:28e6becd-a65a-4245-b282-5766127567a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1649961
  • 1649560

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ProAir RespiClick" or generic name "Albuterol Sulfate"

    NDCBrand NameGeneric Name
    53002-1750ProAir RespiClickProAir RespiClick
    59310-580ProAir RespiClickProAir RespiClick
    0378-0255Albuterolalbuterol sulfate
    0378-0572Albuterolalbuterol sulfate
    0054-0742Albuterol SulfateAlbuterol Sulfate
    0093-3174Albuterol SulfateAlbuterol Sulfate
    0254-1007Albuterol SulfateAlbuterol Sulfate
    0378-4122Albuterol Sulfatealbuterol sulfate
    0378-4124Albuterol Sulfatealbuterol sulfate
    0378-6991Albuterol Sulfatealbuterol sulfate
    0378-6992Albuterol Sulfatealbuterol sulfate
    0378-7057Albuterol SulfateAlbuterol Sulfate
    0378-7058Albuterol SulfateAlbuterol Sulfate
    0378-8270Albuterol SulfateAlbuterol Sulfate
    0085-1132Proventil HFAAlbuterol Sulfate
    0173-0682VENTOLINalbuterol sulfate

    Trademark Results [ProAir RespiClick]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROAIR RESPICLICK
    PROAIR RESPICLICK
    86423378 4847572 Live/Registered
    Teva Respiratory, LLC
    2014-10-14
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.