NDC 42291-153

AZELASTINE HYDROCHLORIDE

Azelastine Hydrochloride

AZELASTINE HYDROCHLORIDE is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Azelastine Hydrochloride.

Product ID42291-153_763cd826-38a9-362d-e053-2991aa0ac0d8
NDC42291-153
Product TypeHuman Prescription Drug
Proprietary NameAZELASTINE HYDROCHLORIDE
Generic NameAzelastine Hydrochloride
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2016-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA090176
Labeler NameAvKARE, Inc.
Substance NameAZELASTINE HYDROCHLORIDE
Active Ingredient Strength137 ug/.137mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-153-30

1 BOTTLE, SPRAY in 1 CARTON (42291-153-30) > 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-153-30 [42291015330]

AZELASTINE HYDROCHLORIDE SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA090176
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-04-01

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/.137mL

OpenFDA Data

SPL SET ID:90e9eeb3-9583-da47-ceb4-ed530fb8287f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797867

    • Pharmacological Class

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

    NDC Crossover Matching brand name "AZELASTINE HYDROCHLORIDE" or generic name "Azelastine Hydrochloride"

    NDCBrand NameGeneric Name
    0054-0293Azelastine HydrochlorideAzelastine Hydrochloride
    0832-0290Azelastine HydrochlorideAzelastine Hydrochloride
    17478-718Azelastine HydrochlorideAzelastine Hydrochloride
    42291-094Azelastine HydrochlorideAzelastine
    42291-153AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    47335-779Azelastine HydrochlorideAzelastine Hydrochloride
    47335-938Azelastine HydrochlorideAzelastine Hydrochloride
    50090-2330Azelastine Hydrochlorideazelastine hydrochloride
    50090-2538Azelastine HydrochlorideAzelastine Hydrochloride
    50090-3833Azelastine HydrochlorideAzelastine
    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
    68071-4359Azelastine HydrochlorideAzelastine Hydrochloride
    68382-415AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    70771-1313AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    76519-1222AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    60505-0578AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
    60505-0848Azelastine HydrochlorideAzelastine Hydrochloride
    60505-0833Azelastine HydrochlorideAzelastine Hydrochloride
    61314-308Azelastine HydrochlorideAzelastine Hydrochloride
    65162-706Azelastine HydrochlorideAzelastine Hydrochloride
    65162-676Azelastine HydrochlorideAzelastine Hydrochloride
    70069-091Azelastine HydrochlorideAzelastine Hydrochloride
    68083-287Azelastine HydrochlorideAzelastine Hydrochloride
    71205-449Azelastine HydrochlorideAzelastine Hydrochloride
    0037-0241Astelinazelastine hydrochloride
    0037-0242AsteproAzelastine Hydrochloride
    0037-0243AsteproAzelastine Hydrochloride
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