NDC 0280-0065

Astepro Allergy

Azelastine Hcl

Astepro Allergy is a Nasal Spray, Metered in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Azelastine Hydrochloride.

Product ID0280-0065_e277a200-d458-66bb-e053-2a95a90aef13
NDC0280-0065
Product TypeHuman Otc Drug
Proprietary NameAstepro Allergy
Generic NameAzelastine Hcl
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2022-06-27
Marketing CategoryNDA /
Application NumberNDA213872
Labeler NameBayer HealthCare LLC.
Substance NameAZELASTINE HYDROCHLORIDE
Active Ingredient Strength206 ug/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0280-0065-01

60 CARTON in 1 BOTTLE (0280-0065-01) > 1 SPRAY, METERED in 1 CARTON
Marketing Start Date2022-07-05
NDC Exclude FlagN
Sample Package?Y

Drug Details

NDC Crossover Matching brand name "Astepro Allergy" or generic name "Azelastine Hcl"

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

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