NDC 65162-676

Azelastine Hydrochloride

Azelastine

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

Product ID65162-676_5ccc67af-6809-4f15-803a-1f5672c223d9
NDC65162-676
Product TypeHuman Prescription Drug
Proprietary NameAzelastine Hydrochloride
Generic NameAzelastine
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2017-09-05
Marketing CategoryANDA / ANDA
Application NumberANDA204660
Labeler NameAmneal Pharmaceuticals LLC
Substance NameAZELASTINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65162-676-84

1 BOTTLE, SPRAY in 1 CARTON (65162-676-84) > 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date2017-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-676-84 [65162067684]

Azelastine Hydrochloride SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA204660
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-05

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:7902605c-944a-4d7e-a7d4-eb4a71bcacdb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797867
    • UPC Code
  • 0365162676846

    • Pharmacological Class

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

    Medicade Reported Pricing

    65162067684 AZELASTINE 0.1% (137 MCG) SPRY

    Pricing Unit: ML | Drug Type:

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

    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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