NDC 47335-779

Azelastine Hydrochloride

Azelastine Hydrochloride

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

Product ID47335-779_09652cb1-7315-4188-9f36-4e2b50fb764d
NDC47335-779
Product TypeHuman Prescription Drug
Proprietary NameAzelastine Hydrochloride
Generic NameAzelastine Hydrochloride
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2012-05-24
Marketing CategoryANDA / ANDA
Application NumberANDA090423
Labeler NameSun Pharmaceutical Industries, Inc.
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 47335-779-91

1 BOTTLE, SPRAY in 1 BOX (47335-779-91) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date2012-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-779-91 [47335077991]

Azelastine Hydrochloride SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA090423
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-05-24

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/1

OpenFDA Data

SPL SET ID:305c6dc8-8247-473d-9975-b02903af6d53
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797867
  • Pharmacological Class

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

    Medicade Reported Pricing

    47335077991 AZELASTINE 0.1% (137 MCG) SPRY

    Pricing Unit: ML | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.