NDC 45802-026

azelastine hcl nasal

Azelastine Hcl

azelastine hcl nasal is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Azelastine Hydrochloride.

Product ID45802-026_13a7f4f6-f9ad-4072-a70b-b80c4c24059f
NDC45802-026
Product TypeHuman Prescription Drug
Proprietary Nameazelastine hcl nasal
Generic NameAzelastine Hcl
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2014-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA202743
Labeler NamePadagis Israel Pharmaceuticals Ltd
Substance NameAZELASTINE HYDROCHLORIDE
Active Ingredient Strength206 ug/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 45802-026-83

1 BOTTLE in 1 CARTON (45802-026-83) > 200 SPRAY in 1 BOTTLE
Marketing Start Date2014-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45802-026-83 [45802002683]

azelastine hcl nasal SPRAY
Marketing CategoryANDA
Application NumberANDA202743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-05-09

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE205.5 ug/1

OpenFDA Data

SPL SET ID:ccb6046c-3c10-42c6-aa22-23192c21a5fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797883
  • Pharmacological Class

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

    Medicade Reported Pricing

    45802026937 PERMETHRIN 5% CREAM

    Pricing Unit: GM | Drug Type:

    45802026337 CLINDAMYCIN PHOS 1% PLEDGET

    Pricing Unit: EA | Drug Type:

    45802002683 AZELASTINE 0.15% NASAL SPRAY

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "azelastine hcl nasal" or generic name "Azelastine Hcl"

    NDCBrand NameGeneric Name
    45802-026azelastine hcl nasalAzelastine HCl
    63629-2519azelastine hcl nasalAzelastine HCl
    0280-0065Astepro AllergyAzelastine HCl
    0280-0066Children Astepro AllergyAzelastine HCl

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