NDC 0037-0241

Astelin

Azelastine Hydrochloride

Astelin 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 ID0037-0241_cc3b2ad8-2a5a-4d87-9831-715a81bd3549
NDC0037-0241
Product TypeHuman Prescription Drug
Proprietary NameAstelin
Generic NameAzelastine Hydrochloride
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date1996-11-01
Marketing CategoryNDA / NDA
Application NumberNDA020114
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
Listing Certified Through2020-12-31

Packaging

NDC 0037-0241-30

1 BOTTLE, SPRAY in 1 BOX (0037-0241-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date1996-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-0241-05 [00037024105]

Astelin SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA020114
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-08
Marketing End Date2014-11-06

NDC 0037-0241-30 [00037024130]

Astelin SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA020114
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-11-01

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/1

OpenFDA Data

SPL SET ID:46b2ddff-d40a-43ac-b027-4fac9fc2f4b9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797867
  • 1797876

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0037-0241Astelinazelastine hydrochloride
    0037-0242AsteproAzelastine Hydrochloride
    0037-0243AsteproAzelastine 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 [Astelin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ASTELIN
    ASTELIN
    78817861 3260403 Live/Registered
    MEDA PHARMACEUTICALS INC.
    2006-02-17
    ASTELIN
    ASTELIN
    78817480 3260402 Live/Registered
    MEDA PHARMACEUTICALS INC.
    2006-02-17
    ASTELIN
    ASTELIN
    75164746 not registered Dead/Abandoned
    CARTER-WALLACE, INC.
    1996-09-12
    ASTELIN
    ASTELIN
    74711561 2070525 Live/Registered
    MEDA PHARMACEUTICALS INC.
    1995-07-31
    ASTELIN
    ASTELIN
    73564973 1395499 Live/Registered
    CARTER-WALLACE, INC.
    1985-10-25
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