NDC 0037-0242

Astepro

Azelastine Hydrochloride

Astepro is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Azelastine Hydrochloride.

Product ID0037-0242_f3845546-7fac-4305-acdc-b41155408f62
NDC0037-0242
Product TypeHuman Prescription Drug
Proprietary NameAstepro
Generic NameAzelastine Hydrochloride
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2009-10-12
Marketing End Date2020-12-31
Marketing CategoryNDA / NDA
Application NumberNDA022203
Labeler NameMeda Pharmaceuticals
Substance NameAZELASTINE HYDROCHLORIDE
Active Ingredient Strength137 ug/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0037-0242-30

1 BOTTLE, SPRAY in 1 BOX (0037-0242-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date2009-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-0242-57 [00037024257]

Astepro SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022203
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-07
Marketing End Date2012-09-06

NDC 0037-0242-30 [00037024230]

Astepro SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA022203
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-12
Marketing End Date2019-04-25

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/1

OpenFDA Data

SPL SET ID:0e979fc0-353c-11dc-8dea-0002a5d5c51b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797867
  • 1797871
  • 1797883
  • 1797884
    • UPC Code
  • 0300370242308

    • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Astepro" or generic name "Azelastine Hydrochloride"

    NDCBrand NameGeneric Name
    0037-0242AsteproAzelastine Hydrochloride
    0037-0243AsteproAzelastine Hydrochloride
    0037-0241Astelinazelastine hydrochloride
    0054-0293Azelastine HydrochlorideAzelastine Hydrochloride
    0832-0290Azelastine HydrochlorideAzelastine Hydrochloride
    17478-718Azelastine HydrochlorideAzelastine Hydrochloride
    42291-153AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    47335-779Azelastine HydrochlorideAzelastine Hydrochloride
    47335-938Azelastine HydrochlorideAzelastine Hydrochloride
    50090-2330Azelastine Hydrochlorideazelastine hydrochloride
    50090-2538Azelastine HydrochlorideAzelastine Hydrochloride
    50383-738Azelastine HydrochlorideAzelastine Hydrochloride
    50383-942Azelastine HydrochlorideAzelastine Hydrochloride
    51525-0234AZELASTINE HYDROCHLORIDEazelastine hydrochloride
    51525-0294Azelastine HydrochlorideAzelastine Hydrochloride
    51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    53002-1279Azelastine Hydrochlorideazelastine hydrochloride
    53002-2279Azelastine HydrochlorideAzelastine Hydrochloride
    59651-214AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    59651-215AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    60505-0578AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE

    Trademark Results [Astepro]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ASTEPRO
    ASTEPRO
    77457156 3659066 Live/Registered
    Meda Pharmaceuticals Inc.
    2008-04-24
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