azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler a-s medication solutions
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7461
Product ID 50090-7461_6f0629d0-5f20-406f-ad61-cf775f553772
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212289
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

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 500907461
Hyphenated Format 50090-7461

Supplemental Identifiers

RxCUI
1797867
UNII
0L591QR10I

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 azelastine hydrochloride (source: ndc)
Generic Name azelastine hydrochloride (source: ndc)
Application Number ANDA212289 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (50090-7461-0) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

50090-7461-0 1 BOTTLE, SPRAY in 1 CARTON (50090-7461-0) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

azelastine hydrochloride (137 ug/1)

Linked Drug Pages (1)

AZELASTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "6f0629d0-5f20-406f-ad61-cf775f553772", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797867"], "spl_set_id": ["fc9d031d-428d-4d53-8e63-feb96d5ab01a"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (50090-7461-0)  / 200 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "50090-7461-0", "marketing_start_date": "20241119"}], "brand_name": "AZELASTINE HYDROCHLORIDE", "product_id": "50090-7461_6f0629d0-5f20-406f-ad61-cf775f553772", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50090-7461", "generic_name": "AZELASTINE HYDROCHLORIDE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZELASTINE HYDROCHLORIDE", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}], "application_number": "ANDA212289", "marketing_category": "ANDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}