azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
INTRAOCULAR
Active Ingredients

azelastine hydrochloride .5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0578
Product ID 60505-0578_6266ffd5-6ff5-dd31-01f3-a0ac961c826f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078621
Listing Expiration 2026-12-31
Marketing Start 2009-12-01

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 605050578
Hyphenated Format 60505-0578

Supplemental Identifiers

RxCUI
860805
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 azelastine hydrochloride (source: ndc)
Generic Name azelastine hydrochloride (source: ndc)
Application Number ANDA078621 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

60505-0578-4 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

azelastine hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

AZELASTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAOCULAR"], "spl_id": "6266ffd5-6ff5-dd31-01f3-a0ac961c826f", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["77a33738-ffcf-221c-1562-780418882e5d"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4)  / 6 mL in 1 BOTTLE, PLASTIC", "package_ndc": "60505-0578-4", "marketing_start_date": "20091201"}], "brand_name": "AZELASTINE HYDROCHLORIDE", "product_id": "60505-0578_6266ffd5-6ff5-dd31-01f3-a0ac961c826f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "60505-0578", "generic_name": "AZELASTINE HYDROCHLORIDE", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZELASTINE HYDROCHLORIDE", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA078621", "marketing_category": "ANDA", "marketing_start_date": "20091201", "listing_expiration_date": "20261231"}