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AZELASTINE HYDROCHLORIDE .5 mg/mL Solution/ Drops — NDC 46708-0506-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AZELASTINE HYDROCHLORIDE .5 mg/mL Solution/ Drops — NDC 46708-506-06 (Billing 46708-0506-06)

by Alembic Pharmaceuticals Limited · 1 BOTTLE in 1 CARTON / 6 mL in 1 BOTTLE

This is a package of AZELASTINE HYDROCHLORIDE .5 mg/mL Solution/ Drops from Alembic Pharmaceuticals Limited, marketed since Mar 2019 and currently FDA-listed. It is this product's only package size.

NDC 46708-0506-06
🏷️ FDA NDC (as labeled) 46708-506-06 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 46708-506-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
46708 labeler · 506 product · 06 package
Package marketed since
Mar 20, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4670850606 3
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Azelastine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0495-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46708-506-06
Product NDC 46708-506
11-digit billing NDC 46708050606
RxCUI 860805
UNII 0L591QR10I
Application # ANDA209620
SPL Set ID 753d7a69-b0da-4350-9dc5-97f26ebe5cc0
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 2019-03-20
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance AZELASTINE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS
Quick answers
  • RxCUI (RxNorm): 860805
Why two NDCs? The FDA registers this code as 46708-506-06 — a 5-3-2 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 product segment → 46708-0506-06. 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.

RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Other antihistamines for systemic use, Other antiallergics
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 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 ↗
📗 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 →

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.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.79 $10.72 / 6 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
46708-0506-06 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 6 mL in 1 BOTTLE 2019-03-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Azelastine Hydrochloride .5 mg/mL 47335-0938-90 Sun 1 bottle $0.908 — FDA listed —
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/mL 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/mLthis 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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.

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.

  • 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.

Manufacturer & labeler

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA209620 (ANDA)
Labeler code46708
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio502 products on file

More NDCs from Alembic Pharmaceuticals Limited labeler code 46708

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.

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

INDICATIONS & USAGE Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

⏱️ Dosage and Administration 17 words ▾

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

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Azelastine hydrochloride ophthalmic solution 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.

⚠️ Warnings 18 words ▾

WARNINGS Azelastine hydrochloride ophthalmic solution 0.05% is for ocular use only and not for injection or oral use.

🤒 Adverse Reactions 78 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 1–10% 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 137 words ▾

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 14th 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 17 words ▾

PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 have not been established.

🧓 Geriatric Use 18 words ▾

GERIATRIC USE No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

🧬 Clinical Pharmacology ~1 min read ▾

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 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 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 69 words ▾

HOW SUPPLIED Azelastine hydrochloride ophthalmic solution, USP 0.05% is supplied as follows: Azelastine hydrochloride ophthalmic solution, USP 0.05% 6 mL (NDC#46708-506-06) solution in a 10 mL LDPE container with LDPE nozzle and a white HDPE screw cap. Storage Azelastine hydrochloride ophthalmic solution, USP 0.05% : Store UPRIGHT between 2° and 25°C (36° and 77°F). Rx only Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391 450, Gujarat, India.

Revised: 01/2024

📋 Description 157 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: Structural formula: C 22 H 24 ClN 3 O•HCl Each mL of azelastine hydrochloride ophthalmic solution, USP 0.05% 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. azelastine-hydrochloride-str

💬 Information for Patients 137 words ▾

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 or single-use container. Keep bottle tightly closed when not in use. Discard single-use container immediately after 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 ophthalmic solution 0.05% before they insert their contact lenses.

⚠️ Precautions ~2 min read ▾

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 or single-use container. Keep bottle tightly closed when not in use. Discard single-use container immediately after 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 ophthalmic solution 0.05% 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 14th 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 38 words ▾

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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 167 words ▾

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.

📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Azelastine hydrochloride ophthalmic solution, USP 0.05%- Bottle Label - Alembic Azelastine hydrochloride ophthalmic solution, USP 0.05%- Carton Label - Alembic bottle-label-alembic-dm carton-label-alembic-dm

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 46708-0505-03 · Alembic 46708-0507-05 · Alembic →
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.