Azelastine Hydrochloride .5 mg/mL Solution/ Drops — NDC 70069-091-01 (Billing 70069-0091-01)
This is a package of Azelastine Hydrochloride .5 mg/mL Solution/ Drops from Somerset Therapeutics, LLC, marketed since Apr 2019 and currently FDA-listed; retail pharmacies pay about $1.01 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70069-091-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70069 labeler · 091 product · 01 package
- Package marketed since
- Apr 8, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0370069091012
- Medicaid fills, this package
- 75,478 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Azelastine Hydrochloride (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 040646
- GCN: 94615
- GPI-14 (Medi-Span): 86802006102020
- HICL (First Databank): 007607
- AHFS class code: 04:08.00.00
- RxCUI (RxNorm): 860805
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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%.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.012 | $6.07 / 6 ml |
| Medicaid paysCMS SDUD · 12 mo | $2.46 | $14.74 / 6 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.79 | $10.72 / 6 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70069-0091-01 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 6 mL in 1 BOTTLE | 2019-04-08 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Azelastine Hydrochloride .5 mg/mL 47335-0938-90 | Sun | 1 bottle | $0.908 | — | FDA listed | save 10% |
| Azelastine Hydrochloride .5 mg/mL 60505-0578-04 | Apotex | 1 bottle | $1.012 | AT | Availability likely | — |
| Azelastine Hydrochloride .5 mg/mL 61314-0308-02 | Sandoz | 1 bottle | $1.012 | AT | Availability likely | — |
| Azelastine Hydrochloride Ophthalmic Solution 0.05% .5 mg/mL 62332-0506-06 | Alembic | 1 bottle | $1.012 | AT | Availability likely | — |
| Azelastine Hydrochloride .5 mg/mLthis 70069-0091-01 | Somerset | 1 bottle | $1.012 | AT | Availability likely | — |
| Azelastine Hydrochloride .5 mg/mL 72266-0141-01 | Fosun | 1 bottle | $1.012 | 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Azelastine Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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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.
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UNII RN3152OP35
Hypromellose is a plant-based thickener and film-former derived from cellulose. In medicines, it's used to create coatings on tablets and capsules, control how fast the drug dissolves, and improve the product's texture and stability.
-
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.
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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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Somerset Therapeutics, LLC labeler code 70069
- Ropivacaine Hydrochloride 7.5 mg/mL Injection NDC 70069-065-25
- Ropivacaine Hydrochloride 10 mg/mL Injection NDC 70069-066-10
- Ropivacaine Hydrochloride 10 mg/mL Injection NDC 70069-067-10
- Naloxone Hydrochloride .4 mg/mL Injection, Solution NDC 70069-071-10
- Naloxone Hydrochloride .4 mg/mL Injection, Solution NDC 70069-072-10
- Moxifloxacin Hydrochloride 5 mg/mL Solution/ Drops NDC 70069-081-01
- Methocarbamol 100 mg/mL Injection NDC 70069-101-05
- Tropicamide 10 mg/mL Solution/ Drops NDC 70069-121-01
- Tobramycin 3 mg/mL Solution/ Drops NDC 70069-131-01
- Cisatracurium Besylate 2 mg/mL Injection NDC 70069-141-01
- Cisatracurium Besylate 10 mg/mL Injection NDC 70069-151-01
- Cisatracurium Besylate 2 mg/mL Injection NDC 70069-161-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Azelastine hydrochloride ophthalmic solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: The recommended dose is one drop instilled into each affected eye twice a day.
⛔ Contraindications ▾
CONTRAINDICATIONS: Azelastine hydrochloride ophthalmic solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS: Azelastine hydrochloride ophthalmic solution, 0.05% is for ocular use only and not for injection or oral use.
🤒 Adverse Reactions ▾
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 1–10% 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.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Pregnancy Category C. Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68.6 mg/kg/day (57,000 times the recommended ocular human use level). At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus) and the incidence of 14 th rib were increased in rats.
At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels is unknown. There are no adequate and well-controlled studies in pregnant women.
Azelastine hydrochloride ophthalmic solution, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 have not been established.
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Azelastine hydrochloride is a relatively selective histamine H 1 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, 0.05% 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 to 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, 0.05% was more effective than its vehicle in preventing itching associated with allergic conjunctivitis. Azelastine hydrochloride ophthalmic solution, 0.05% 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, 0.05% for two to eight weeks. In these studies, azelastine hydrochloride ophthalmic solution, 0.05% was more effective than its vehicle in relieving itching associated with allergic conjunctivitis.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Azelastine Hydrochloride Ophthalmic Solution USP, 0.05% is supplied as follows: 6 mL (NDC # 70069-091-01) solution in 10 mL natural HDPE bottle plugged with natural LDPE nozzle and white HDPE screw cap. Storage Store UPRIGHT between 2° and 25°C (36° and 77°F). Rx only For Product Inquiry call +1-800-417-9175 Manufactured for: Somerset Therapeutics, LLC.
Somerset, NJ 08873 Made in India Code No.:KR/DRUGS/KTK/28/289/97 Revised: July, 2024 ST-AZL11/P/03 1200997
📋 Description ▾
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 following chemical structure: Empirical chemical structure: C 22 H 24 ClN 3 O•HCl Each mL of Azelastine hydrochloride ophthalmic solution USP 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, hypromellose, sorbitol solution, sodium hydroxide and water for injection.
It has a pH of approximately 5.0 to 6.5 and an osmolarity of approximately 271 to 312 mOsmol/L. Image
💬 Information for Patients ▾
Information for Patients: To prevent contaminating the dropper tip and solution, care should be taken not to touch any surface, the eyelids, or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. This product is sterile when packaged.
Patients should be advised not to wear a contact lens if their eye is red. Azelastine hydrochloride ophthalmic solution, 0.05% should not be used to treat contact lens related irritation. The preservative in azelastine hydrochloride ophthalmic solution, 0.05%, benzalkonium chloride, may be absorbed by soft contact lenses.
Patients who wear soft contact lenses and whose eyes are not red , should be instructed to wait at least ten minutes after instilling azelastine hydrochloride before they insert their contact lenses.
⚠️ Precautions ▾
PRECAUTIONS: Information for Patients: To prevent contaminating the dropper tip and solution, care should be taken not to touch any surface, the eyelids, or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. This product is sterile when packaged.
Patients should be advised not to wear a contact lens if their eye is red. Azelastine hydrochloride ophthalmic solution, 0.05% should not be used to treat contact lens related irritation. The preservative in azelastine hydrochloride ophthalmic solution, 0.05%, benzalkonium chloride, may be absorbed by soft contact lenses.
Patients who wear soft contact lenses and whose eyes are not red , should be instructed to wait at least ten minutes after instilling azelastine hydrochloride before they insert their contact lenses. Carcinogenesis, Mutagenesis, Impairment of Fertility: Azelastine hydrochloride administered orally for 24 months was not carcinogenic in rats and mice at doses up to 30 mg/kg/day and 25 mg/kg/day, respectively. Based on a 30 μL drop size, these doses were approximately 25,000 and 21,000 times higher than the maximum recommended ocular human use level of 0.001 mg/kg/day for a 50 kg adult.
Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow. Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 25,000 times the maximum recommended ocular human use level. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level), the duration of the estrous cycle was prolonged and copulatory activity and the number of pregnancies were decreased.
The numbers of corpora lutea and implantations were decreased; however, the implantation ratio was not affected. Pregnancy: Teratogenic Effects: Pregnancy Category C. Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68.6 mg/kg/day (57,000 times the recommended ocular human use level).
At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus) and the incidence of 14 th rib were increased in rats. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels is unknown.
There are no adequate and well-controlled studies in pregnant women. Azelastine hydrochloride ophthalmic solution, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether azelastine hydrochloride is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when azelastine hydrochloride ophthalmic solution, 0.05% is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🍼 Nursing Mothers ▾
Nursing Mothers: It is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azelastine hydrochloride ophthalmic solution, 0.05% is administered to a nursing woman.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label Carton Label Container Label Carton Label