Home › NDC Lookup › RxCUI directory › RxCUI 860805

Azelastine hydrochloride 0.5 MG/ML Ophthalmic Solution — RxCUI 860805

Name: Azelastine hydrochloride 0.5 MG/ML Ophthalmic Solution (RxCUI 860805)
Creator: Brian Staiger, PharmD

RxNorm drug concept · Semantic clinical drug

RxCUI 860805 Semantic clinical drug · SCD ● Current RxNorm concept 8 FDA products 8 package NDCs Snapshot Jul 14, 2026

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public NLM RxNorm and FDA (openFDA NDC directory) data sources. Editorial policy

What you’re looking at: the standardized identity of one medicine, as the U.S. drug-data system sees it. Below — every FDA-listed product, package code, price benchmark, and billing code that maps to it.

🗂️ Key Facts

RxCUI860805

Official nameAzelastine hydrochloride 0.5 MG/ML Ophthalmic Solution

Concept typeSemantic clinical drug (SCD)

RxNorm statusCurrent RxNorm concept

Also known asazelastine hydrochloride 0.05 % Ophthalmic Solution; azelastine HCl 0.05 % Ophthalmic Solution

FDA products mapped8

Package NDCs mapped8

Reported Medicaid activity (SDUD)347,051 prescriptions · 45 state & territory Medicaid programs · latest period Q4 2025

RxNorm release07/06/2026

Snapshot dataJul 14, 2026

📖 Skip the Codes — Read It in Plain English.

Our pharmacist-built guide to Azelastine Ophthalmic: what it is, how it’s used, side effects, and interactions.

📗 Our plain-language guide HelloPharmacist

They treat itchy eyes caused by allergic conjunctivitis, which is an allergic reaction affecting the eye. They are not described for other eye problems.
Put one drop in each affected eye, usually twice a day. Follow your prescriber's directions and your label. They are for the eyes only, so never swallow them or inject them.
They might. About 30% of people notice brief burning or stinging. It is usually mild and short-lived.
A bitter taste was reported by about 10% of people using the drops. It is usually mild. Headache is also fairly common, at about 15%.

📖 Read our full Azelastine Ophthalmic guide →

🕸️ Concept Web — How Azelastine hydrochloride 0.5 MG/ML Ophthalmic So... Connects

One RxCUI never lives alone. Follow the path from the raw ingredient down to the exact strength-and-form concepts FDA products carry — every stop is a real RxNorm concept with its own identifier. Hover or focus any chip for what it means.

This page's concept Azelastine hydrochloride 0.5 MG/ML Ophthalmic Solution RxCUI 860805 Semantic clinical drug · SCD

Every web starts here: one RxCUI, one fixed meaning in the RxNorm vocabulary.

Ingredients 2

The active substance itself — no strength, form, or brand attached yet.
- Azelastine 18603 IN
- Azelastine hydrochloride 235824 PIN
Dose forms 6

The ingredient poured into a form — tablet, solution, cream — still without one fixed strength.
- Azelastine Ophthalmic Solution 636216 SCDF
- Azelastine hydrochloride Ophthalmic Solution 2647269 SCDFP
- Azelastine Ophthalmic Product 1158843 SCDG
- Azelastine hydrochloride Ophthalmic Product 2662668 SCDGP
- Ophthalmic Solution 7670 DF
- Ophthalmic Product 1151135 DFG
Clinical & branded drugs 1

Ingredient + strength + dose form. These are the concepts real FDA products actually carry.
- Azelastine hydrochloride 0.5 MG/ML 860804 SCDC

Showing up to 8 concepts per family — 9 of 9 stored related concepts drawn.

These are official RxNorm vocabulary relationships — how concepts name and organize the same medicine. They do not establish therapeutic equivalence or substitutability: two concepts appearing in one web is never a statement that products can be swapped.

🔀 Generic ⇄ Brand Crosswalk

The same medicine has an unbranded (generic) identity and one or more brand-name identities — each with its own RxCUI. This is a naming relationship in RxNorm, not a statement that any two products are substitutable.

Generic (Clinical) Concepts

Azelastine hydrochloride 0.5 MG/ML SCDC · 860804
Azelastine Ophthalmic Solution SCDF · 636216
Azelastine hydrochloride Ophthalmic Solution SCDFP · 2647269
Azelastine Ophthalmic Product SCDG · 1158843
Azelastine hydrochloride Ophthalmic Product SCDGP · 2662668

📦 FDA Products & Package NDCs

8 products · 8 package NDCs

8 package NDCs map to RxCUI 860805 in the current snapshot — up to 50 per page. Each linked NDC opens its full package page.

Package NDC	Package	Brand / generic name	Labeler	Marketing start
46708-0506-06	1 BOTTLE in 1 CARTON (46708-506-06) / 6 mL in 1 BOTTLE	AZELASTINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	2019-03-20
47335-0938-90	1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) / 6 mL in 1 BOTTL...	Azelastine Hydrochloride	Sun Pharmaceutical Industries, Inc.	2010-05-31
60505-0578-04	1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BO...	AZELASTINE HYDROCHLORIDE	Apotex Corp.	2009-12-01
61314-0308-02	1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 6 mL in 1 BO...	Azelastine Hydrochloride	Sandoz Inc	2013-03-21
62332-0506-06	1 BOTTLE in 1 CARTON (62332-506-06) / 6 mL in 1 BOTTLE	Azelastine Hydrochloride Ophthalmic Solution 0.05%	Alembic Pharmaceuticals Inc.	2019-03-20
68083-0287-01	1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTL...	Azelastine Hydrochloride	Gland Pharma Limited	2020-02-25
70069-0091-01	1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE	Azelastine Hydrochloride	Somerset Therapeutics, LLC	2019-04-08
72266-0141-01	1 BOTTLE, PLASTIC in 1 CARTON (72266-141-01) / 6 mL in 1 BO...	Azelastine Hydrochloride	Fosun Pharma USA Inc	2020-09-08

Observed labelers: Alembic Pharmaceuticals Inc. (1) · Alembic Pharmaceuticals Limited (1) · Apotex Corp. (1) · Fosun Pharma USA Inc (1) · Gland Pharma Limited (1) · Sandoz Inc (1) · +2 more — this is the FDA-listed mapping footprint, not sales, inventory, availability, or market share.

🗃️ Sources & Limits

Atlas generation902fddb9-e9c1-4004-bf4c-dba4d51037c7

openFDA export observedJul 14, 2026

RxNorm release07/06/2026

Methodology2026-07-full-catalog-v1

A shared RxCUI does not prove interchangeability. Products mapped to the same concept are not thereby equivalent or substitutable — equivalence is a separate, product-level determination.
Listing here does not establish approval or coverage. Appearing in this snapshot is a data observation, not an FDA approval status or a payer coverage decision.
Missing data never means zero. A silent dataset (no price, no billing code, no utilization) means no observation — not that the real-world value is zero.
Counts describe the mapping footprint. Product, package, and labeler counts are the FDA-listed mapping footprint in this snapshot — not sales, inventory, availability, or market share.

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.

Machine-readable JSON

Reference information about drug-concept identifiers and public regulatory data — not medical advice. Talk to your pharmacist or prescriber about your own medication.