azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

azelastine hydrochloride .5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-091
Product ID 70069-091_9d82b566-97da-4162-a649-b44f3e516d9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207411
Listing Expiration 2026-12-31
Marketing Start 2019-04-08

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 70069091
Hyphenated Format 70069-091

Supplemental Identifiers

RxCUI
860805
UPC
0370069091012
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 ANDA207411 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-091-01 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE

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": ["OPHTHALMIC"], "spl_id": "9d82b566-97da-4162-a649-b44f3e516d9a", "openfda": {"upc": ["0370069091012"], "unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["72406ded-7886-41fb-b5c8-2d27a149aa34"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-091-01)  / 6 mL in 1 BOTTLE", "package_ndc": "70069-091-01", "marketing_start_date": "20190408"}], "brand_name": "Azelastine Hydrochloride", "product_id": "70069-091_9d82b566-97da-4162-a649-b44f3e516d9a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70069-091", "generic_name": "Azelastine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA207411", "marketing_category": "ANDA", "marketing_start_date": "20190408", "listing_expiration_date": "20261231"}