azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler gland pharma limited
Dosage Form SOLUTION/ DROPS
Routes
INTRAOCULAR
Active Ingredients

azelastine hydrochloride .5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-287
Product ID 68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210092
Listing Expiration 2026-12-31
Marketing Start 2020-02-25

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 68083287
Hyphenated Format 68083-287

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 ANDA210092 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

68083-287-01 1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 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": "a29e9f18-dc8f-491a-b502-e26c0d8bfe08", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["f358cecd-284f-4d0b-806c-039465220bd2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (68083-287-01)  / 6 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68083-287-01", "marketing_start_date": "20200225"}], "brand_name": "Azelastine Hydrochloride", "product_id": "68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68083-287", "generic_name": "Azelastine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA210092", "marketing_category": "ANDA", "marketing_start_date": "20200225", "listing_expiration_date": "20261231"}