NDC 53002-3477

QVAR REDIHALER

Beclomethasone Dipropionate Hfa

QVAR REDIHALER is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Beclomethasone Dipropionate.

Product ID53002-3477_67896974-da7b-4189-94f3-2f291147678d
NDC53002-3477
Product TypeHuman Prescription Drug
Proprietary NameQVAR REDIHALER
Generic NameBeclomethasone Dipropionate Hfa
Dosage FormAerosol, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-02-15
Marketing CategoryNDA / NDA
Application NumberNDA207921
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameBECLOMETHASONE DIPROPIONATE
Active Ingredient Strength80 ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-3477-3

1 INHALER in 1 CARTON (53002-3477-3) > 1 AEROSOL, METERED in 1 INHALER
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-3477-3 [53002347703]

QVAR REDIHALER AEROSOL, METERED
Marketing CategoryNDA
Application NumberNDA207921
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BECLOMETHASONE DIPROPIONATE80 ug/1

OpenFDA Data

SPL SET ID:9fb78667-7db9-4d98-b8a2-0de60458de11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1998772
  • 1998773
  • 1998771
  • 1998774

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "QVAR REDIHALER" or generic name "Beclomethasone Dipropionate Hfa"

    NDCBrand NameGeneric Name
    50090-3459QVAR REDIHALERBeclomethasone Dipropionate HFA
    50090-5031QVAR REDIHALERBeclomethasone Dipropionate HFA
    50090-5032QVAR REDIHALERBeclomethasone Dipropionate HFA
    53002-2436QVAR REDIHALERBeclomethasone Dipropionate HFA
    53002-3477QVAR REDIHALERBeclomethasone Dipropionate HFA
    59310-302QVAR REDIHALERBeclomethasone Dipropionate HFA
    59310-304QVAR REDIHALERBeclomethasone Dipropionate HFA

    Trademark Results [QVAR REDIHALER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    QVAR REDIHALER
    QVAR REDIHALER
    97872541 not registered Live/Pending
    IVAX LLC
    2023-04-04
    QVAR REDIHALER
    QVAR REDIHALER
    86433534 5438539 Live/Registered
    Ivax LLC
    2014-10-24
    QVAR REDIHALER
    QVAR REDIHALER
    86364210 5433697 Live/Registered
    IVAX, LLC
    2014-08-12
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