astepro allergy

Generic: azelastine hcl

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name astepro allergy
Generic Name azelastine hcl
Labeler bayer healthcare llc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 205.5 ug/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 0280-0065
Product ID 0280-0065_452641af-4731-7fc3-e063-6394a90abceb
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA213872
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02800065
Hyphenated Format 0280-0065

Supplemental Identifiers

RxCUI
1797883 1797884
UNII
0L591QR10I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name astepro allergy (source: ndc)
Generic Name azelastine hcl (source: ndc)
Application Number NDA213872 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 205.5 ug/1
source: ndc
Packaging
  • 60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON
  • 120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON
  • 120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE
  • 200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON
  • 22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON
  • 120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTON
  • 22 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTON
source: ndc

Packages (7)

0280-0065-01 60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON 0280-0065-02 120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON 0280-0065-03 120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE 0280-0065-04 200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON 0280-0065-05 22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON 0280-0065-09 120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTON 0280-0065-10 22 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTON

Ingredients (1)

azelastine hydrochloride (205.5 ug/1)

Linked Drug Pages (1)

Astepro Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "452641af-4731-7fc3-e063-6394a90abceb", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797883", "1797884"], "spl_set_id": ["e0640846-19a6-7f79-e053-2995a90a8176"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "60 CARTON in 1 BOTTLE (0280-0065-01)  / 1 SPRAY, METERED in 1 CARTON", "package_ndc": "0280-0065-01", "marketing_start_date": "20220705"}, {"sample": false, "description": "120 CARTON in 1 BOTTLE (0280-0065-02)  / 1 SPRAY, METERED in 1 CARTON", "package_ndc": "0280-0065-02", "marketing_start_date": "20220705"}, {"sample": false, "description": "120 PACKAGE in 1 BOTTLE (0280-0065-03)  / 3 SPRAY, METERED in 1 PACKAGE", "package_ndc": "0280-0065-03", "marketing_start_date": "20220705"}, {"sample": false, "description": "200 CARTON in 1 BOTTLE (0280-0065-04)  / 1 SPRAY, METERED in 1 CARTON", "package_ndc": "0280-0065-04", "marketing_start_date": "20220705"}, {"sample": true, "description": "22 CARTON in 1 BOTTLE (0280-0065-05)  / 1 SPRAY, METERED in 1 CARTON", "package_ndc": "0280-0065-05", "marketing_start_date": "20230124"}, {"sample": false, "description": "120 CARTON in 1 BOTTLE (0280-0065-09)  / 2 SPRAY, METERED in 1 CARTON", "package_ndc": "0280-0065-09", "marketing_start_date": "20220705"}, {"sample": false, "description": "22 CARTON in 1 BOTTLE (0280-0065-10)  / 1 SPRAY, METERED in 1 CARTON", "package_ndc": "0280-0065-10", "marketing_start_date": "20220705"}], "brand_name": "Astepro Allergy", "product_id": "0280-0065_452641af-4731-7fc3-e063-6394a90abceb", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0280-0065", "generic_name": "Azelastine HCl", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Astepro Allergy", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "205.5 ug/1"}], "application_number": "NDA213872", "marketing_category": "NDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}