NDC 0832-0290

Azelastine Hydrochloride

Azelastine Hydrochloride

Azelastine Hydrochloride is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Inc.. The primary component is Azelastine Hydrochloride.

Product ID0832-0290_d5581ffe-d48a-46f5-8303-691f5195d4a2
NDC0832-0290
Product TypeHuman Prescription Drug
Proprietary NameAzelastine Hydrochloride
Generic NameAzelastine Hydrochloride
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2017-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA202609
Labeler NameUpsher-Smith Laboratories, 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 0832-0290-30

1 BOTTLE, SPRAY in 1 CARTON (0832-0290-30) > 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date2017-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0832-0290-30 [00832029030]

Azelastine Hydrochloride SPRAY
Marketing CategoryANDA
Application NumberANDA202609
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-17
Marketing End Date2017-03-17

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/.137mL

OpenFDA Data

SPL SET ID:415b75cf-2fec-4b64-ab0f-6fbd830a9641
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797867
    • UPC Code
  • 0436320290300

    • 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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