NDC 70069-091

Azelastine Hydrochloride

Azelastine Hydrochloride

Azelastine Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Azelastine Hydrochloride.

Product ID70069-091_1cce2504-6771-48ed-88fb-ac705510dd99
NDC70069-091
Product TypeHuman Prescription Drug
Proprietary NameAzelastine Hydrochloride
Generic NameAzelastine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-04-08
Marketing CategoryANDA / ANDA
Application NumberANDA207411
Labeler NameSomerset Therapeutics, 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 70069-091-01

1 BOTTLE in 1 CARTON (70069-091-01) > 6 mL in 1 BOTTLE
Marketing Start Date2019-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-091-01 [70069009101]

Azelastine Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA207411
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-08

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:72406ded-7886-41fb-b5c8-2d27a149aa34
Manufacturer
UNII
UPC Code
  • 0370069091012
  • 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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