Home › NDC Lookup › Ingredients › Azelastine Hydrochloride › 60505-0578-04
AZELASTINE HYDROCHLORIDE .5 mg/mL Solution/ Drops — NDC 60505-0578-04 package photo

AZELASTINE HYDROCHLORIDE .5 mg/mL Solution/ Drops

by Apotex Corp. · 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTIC
NDC 60505-0578-04
🏷️ FDA NDC (as labeled) 60505-0578-4 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0495-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 60505-0578-4
Product NDC 60505-0578
11-digit billing NDC 60505057804
NCPDP billing unit ML — per mL (volume)
UNII 0L591QR10I
Application # ANDA078621
SPL Set ID 77a33738-ffcf-221c-1562-780418882e5d
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-12-01
Route INTRAOCULAR
Dosage form SOLUTION/ DROPS
Substance AZELASTINE HYDROCHLORIDE
GCN Seq No 040646
GCN 94615
HICL code 007607
Ingredient (HICL) Azelastine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6R
Therapeutic class — specific (HIC3) Eye Antihistamines
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name AZELASTINE HCL 0.05% DROPS
FDB brand name Azelastine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 60505-0578-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 60505-0578-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA078621 (ANDA)
Labeler code60505
First marketedDec 2009
Product typeHuman Prescription Drug
Portfolio306 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name AZELASTINE HCL 0.05% DROPS Ingredient Azelastine Hcl
📖 What it is MedlinePlus · NLM

Azelastine ophthlamic is used to relieve the itching of allergic pink eye. Azelastine is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.125 mg / 1 mL UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.005 $6.03 / 6 ml
Medicaid paysCMS SDUD · 12 mo $2.48 $14.87 / 6 ml
Medicare drug plans payPart D · Q2 2026 $1.79 $10.72 / 6 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.300 $0.879
▼ Down 17% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Azelastine Hydrochloride .5 mg/mL 47335-0938-90 Sun 1 bottle $0.908 — FDA listed save 10%
Azelastine Hydrochloride .5 mg/mLthis 60505-0578-04 Apotex 1 bottle $1.005 AT Availability likely —
Azelastine Hydrochloride .5 mg/mL 61314-0308-02 Sandoz 1 bottle $1.005 AT Availability likely —
Azelastine Hydrochloride Ophthalmic Solution 0.05% .5 mg/mL 62332-0506-06 Alembic 1 bottle $1.005 AT Availability likely —
Azelastine Hydrochloride .5 mg/mL 70069-0091-01 Somerset 1 bottle $1.005 AT Availability likely —
Azelastine Hydrochloride .5 mg/mL 72266-0141-01 Fosun 1 bottle $1.005 AT Availability likely —
Azelastine Hydrochloride .5 mg/mL 46708-0506-06 Alembic 1 bottle — AT FDA listed —
Azelastine Hydrochloride .5 mg/mL 68083-0287-01 Gland 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2009
On the market since
Dec 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 60505-0578-04, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
199K
Units reimbursed last 4 qtrs
1.3M
Gross reimbursed last 4 qtrs
$3.22M
Avg / prescription
$16.20
Avg / unit
$2.4779
Latest quarter Q4 2025
38.4KRx
Medicaid pays / mL
$2.4779
gross reimbursed
vs
NADAC / mL
$1.0052
acquisition cost
=
Spread
+$1.4727
+147% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
77% FFS 23% MCO
Fee-for-service · 153,714 Rx Managed care · 45,316 Rx
State Medicaid map
Alaska: no data reported AK Maine: 558 units · 40.0 per 100k residents ME Washington: 108 units · 1.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 300 units · 5.2 per 100k residents MN Wisconsin: 623 units · 10.5 per 100k residents WI Michigan: 12,135 units · 121 per 100k residents MI New York: 580,849 units · 2,968 per 100k residents NY Vermont: 84 units · 13.0 per 100k residents VT New Hampshire: 552 units · 39.4 per 100k residents NH Oregon: 1,440 units · 34.0 per 100k residents OR Nevada: 2,437 units · 76.3 per 100k residents NV Wyoming: no data reported WY South Dakota: 433 units · 47.1 per 100k residents SD Iowa: 9,228 units · 288 per 100k residents IA Illinois: 39,117 units · 312 per 100k residents IL Indiana: 34,944 units · 509 per 100k residents IN Ohio: 35,272 units · 299 per 100k residents OH Pennsylvania: 31,237 units · 241 per 100k residents PA New Jersey: 24,779 units · 267 per 100k residents NJ Massachusetts: 1,950 units · 27.9 per 100k residents MA California: 401,784 units · 1,031 per 100k residents CA Utah: 588 units · 17.2 per 100k residents UT Colorado: 942 units · 16.0 per 100k residents CO Nebraska: no data reported NE Missouri: 3,420 units · 55.2 per 100k residents MO Kentucky: 1,626 units · 35.9 per 100k residents KY West Virginia: 4,956 units · 280 per 100k residents WV Virginia: 3,872 units · 44.4 per 100k residents VA Maryland: 21,514 units · 348 per 100k residents MD Connecticut: 2,718 units · 75.1 per 100k residents CT Rhode Island: 516 units · 47.1 per 100k residents RI Arizona: 6,378 units · 85.8 per 100k residents AZ New Mexico: 822 units · 38.9 per 100k residents NM Kansas: 258 units · 8.8 per 100k residents KS Arkansas: 2,010 units · 65.5 per 100k residents AR Tennessee: 1,806 units · 25.3 per 100k residents TN North Carolina: 480 units · 4.4 per 100k residents NC South Carolina: no data reported SC Delaware: 3,120 units · 303 per 100k residents DE Oklahoma: no data reported OK Louisiana: 12,912 units · 282 per 100k residents LA Mississippi: 2,160 units · 73.5 per 100k residents MS Alabama: 10,924 units · 214 per 100k residents AL Georgia: 3,144 units · 28.5 per 100k residents GA D.C.: 1,827 units · 269 per 100k residents DC Hawaii: 8,148 units · 568 per 100k residents HI Texas: 3,582 units · 11.7 per 100k residents TX Florida: 25,710 units · 114 per 100k residents FL
Units reimbursed · per 100k residents
1.42,968
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 2,968 /100k
2 California 1,031 /100k
3 Hawaii 568 /100k
4 Indiana 509 /100k
5 Maryland 348 /100k
6 Illinois 312 /100k
7 Delaware 303 /100k
8 Ohio 299 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AZELASTINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Treatment Failure783
Fatigue737
Dyspnoea707
Headache680
Cough614
Nausea560
Sinusitis502

Age at onset

Neonate2
Child45
Adolescent64
Adult1,636
Elderly1,214

Reporter sex

10,538 reports
Male · 31%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization1,718
Death191
Disabling187
Life-threatening131
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,522 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
60505-0578-04 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTIC 2009-12-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

⏱️ Dosage and Administration 17 words ▾

DOSAGE AND ADMINISTRATION The recommended dose is one drop instilled into each affected eye twice a day.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.

⚠️ Warnings 18 words ▾

WARNINGS Azelastine hydrochloride ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.

🤒 Adverse Reactions 80 words ▾

ADVERSE REACTIONS In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1 to 10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring.

Some of these events were similar to the underlying disease being studied.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Azelastine hydrochloride is a relatively selective histamine H1 antagonist and an inhibitor of the release of histamine and other mediators from cells (e.g. mast cells) involved in the allergic response. Based on in vitro studies using human cell lines, inhibition of other mediators involved in allergic reactions (e.g. leukotrienes and PAF) has been demonstrated with azelastine hydrochloride. Decreased chemotaxis and activation of eosinophils has also been demonstrated.

Pharmacokinetics and Metabolism Absorption of azelastine following ocular administration was relatively low. A study in symptomatic patients receiving one drop of azelastine hydrochloride ophthalmic solution in each eye two to four times a day (0.06 to 0.12 mg azelastine hydrochloride) demonstrated plasma concentrations of azelastine hydrochloride to generally be between 0.02 and 0.25 ng/mL after 56 days of treatment. Three of nineteen patients had quantifiable amounts of N-desmethylazelastine that ranged from 0.25 - 0.87 ng/mL at Day 56.

Based on intravenous and oral administration, the elimination half-life, steady-state volume of distribution and plasma clearance were 22 hours,

14.5 L/kg and

0.5L/h/kg, respectively. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Azelastine hydrochloride is oxidatively metabolized to the principal metabolite, N-desmethylazelastine, by the cytochrome P450 enzyme system.

In vitro studies in human plasma indicate that the plasma protein binding of azelastine and N-desmethylazelastine are approximately 88% and 97% respectively. Clinical Trials In a conjunctival antigen challenge study, azelastine hydrochloride ophthalmic solution was more effective than its vehicle in preventing itching associated with allergic conjunctivitis. Azelastine hydrochloride ophthalmic solution had a rapid (within 3 minutes) onset of effect and a duration of effect of approximately 8 hours for the prevention of itching.

In environmental studies, adult and pediatric, patients with seasonal allergic conjunctivitis were treated with azelastine hydrochloride ophthalmic solution for two to eight weeks. In these studies, azelastine hydrochloride ophthalmic solution was more effective than its vehicle in relieving itching associated with allergic conjunctivitis.

📦 How Supplied / Storage and Handling 74 words ▾

HOW SUPPLIED Azelastine Hydrochloride Ophthalmic Solution USP, 0.05% is supplied as follows: 6 mL (NDC# 60505-0578-4) solution in a translucent 11 mL HDPE container with a LDPE dropper tip, and a white HDPE screw cap. Storage Store UPRIGHT at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature]. Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% Manufactured by: Manufactured for: Apotex Inc.

Apotex Corp. Toronto, Ontario Weston, FL Canada M9L 1T9 33326 September 2025

📋 Description 146 words ▾

DESCRIPTION Azelastine Hydrochloride Ophthalmic Solution USP, 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H 1 -receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a white crystalline powder with a molecular weight of 418.37. Azelastine hydrochloride is sparingly soluble in water, methanol and propylene glycol, and slightly soluble in ethanol, octanol, and glycerine.

Azelastine hydrochloride is a racemic mixture with a melting point of 225°C. The chemical name for azelastine hydrochloride is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride and is represented by the following chemical structure: Each mL of azelastine hydrochloride ophthalmic solution contains: Active: 0.5 mg azelastine hydrochloride, equivalent to 0.457 mg of azelastine base; Preservative: 0.125 mg benzalkonium chloride; Inactives: disodium edetate dihydrate, hydroxypropylmethylcellulose, sodium hydroxide, sorbitol solution and water for injection.

It has a pH of approximately 5.0 to 6.5 and an osmolality of approximately 265 to 375 mOsmol/kg.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 60505-0577-01 · Apotex 60505-0582-04 · Apotex →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.