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Azelastine Hydrochloride 205.5 ug Spray, Metered — NDC 69168-0478-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Azelastine Hydrochloride 205.5 ug Spray, Metered — NDC 69168-478-02 (Billing 69168-0478-02)

by Allegiant Health · 2 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

This is a package of Azelastine Hydrochloride 205.5 ug Spray, Metered from Allegiant Health, marketed since May 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69168-0478-02
🏷️ FDA NDC (as labeled) 69168-478-02 billing pads the product segment with a zero
This package
Contains120 spray, metered in 1 bottle, spray Pack sizes2 compare ↓
Main listing for product 69168-478 · Also comes in: 1 bottle 69168-478-63
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

⚠️
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) 69168-478-02
Product NDC 69168-478
11-digit billing NDC 69168047802
RxCUI 1797883
UNII 0L591QR10I
Application # ANDA216421
SPL Set ID 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112
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 2025-05-02
Route NASAL
Dosage form SPRAY, METERED
Substance AZELASTINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1797883
Why two NDCs? The FDA registers this code as 69168-478-02 — 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 → 69168-0478-02. 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 nasal spray is used to treat allergy symptoms: sneezing runny or itchy nose congestion Azelastine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves symptoms of seasonal allergic rhinitis (hay fever) in adults and children 5 and older. It also treats vasomotor rhinitis, a non-allergic runny or stuffy nose, in people...
  • Spray it only in your nose, never in your eyes or mouth. Prime a new bottle with 6 sprays until you see a fine mist, and reprime with 2 sprays if you haven't used it in 3 or more d...
  • A bitter taste is the most common side effect. Tilting your head downward while you spray can help avoid it.
  • Drowsiness can happen, so be careful driving or operating machinery until you know how it affects you. Avoid alcohol, sedatives and tranquilizers, since they can make drowsiness wo...
📖 Read our full Azelastine Nasal Spray 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 bottle
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
69168-0478-02 You're viewing this Main listing 2 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2025-09-22 — Active
69168-0478-63 69168-478-63 1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2025-09-22 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray.
What NDC number is used to bill for this package of Azelastine Hydrochloride 205.5 ug Spray, Metered?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Astepro Allergy 205.5 ug 00280-0065-01 Bayer 1 bottle — — FDA listed —
Children Astepro Allergy 205.5 ug 00280-0066-01 Bayer 1 bottle — — FDA listed —
Azelastine Hydrochloride 205.5 ug 00363-0653-02 Walgreens 120 sprays — — FDA listed —
Azelastine Hydrochloride 205.5 ug 51316-0840-01 CVS 1 bottle — — FDA listed —
Azelastine Hydrochloride 205.5 ug 58602-0020-07 Aurohealth 1 bottle — — FDA listed —
Azelastine Hydrochloride 205.5 ugthis 69168-0478-02 Allegiant 2 bottles — — FDA listed —
Azelastine Hydrochloride 205.5 ug 69168-0479-64 Allegiant 1 bottle — — FDA listed —
Azelastine HCl 205.5 ug 69238-2147-03 Amneal 1 bottle — — FDA listed —
Azelastine Hydrochloride 205.5 ug 73581-0500-01 YYBA 1 bottle — — 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

💡 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesbenzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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

LabelerAllegiant Health
Application holderAPOTEX INC
FDA applicationANDA216421 (ANDA)
Labeler code69168
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio113 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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

⏱️ Dosage and Administration 129 words ▾

Directions Read the User Guide for how to: prime the bottle before first use use the spray prime bottle again if not used for 3 or more days clean the spray nozzle if it gets clogged adults and children 12 years and older This product may be used either once or twice a day: once daily: use 2 sprays in each nostril;OR twice daily: use 1 or 2 sprays in each nostril every 12 hours do not use more than 4 spraysin each nostril in a 24 hour period children 6 years to 11 years an adult should supervise use 1 spray in each nostril every 12 hours do not use more than 2 spraysin each nostril in a 24 hour period children under 6 years do not use

⚠️ Warnings 183 words ▾

Warnings Only for use in the nose. Do not spray in eyes or mouth. Do not use if you have if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had nose injury that has not healed When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth.

To help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs you have severe or frequent nosebleeds If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 11 words ▾

Active ingredient(s) Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 22 words ▾

Do not use if you have if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 23 words ▾

Ask a doctor before use if you have had recent nose ulcers or nose surgery have had nose injury that has not healed

📄 When Using This Product 68 words ▾

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs you have severe or frequent nosebleeds

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 10 words ▾

Questions/Comments Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)

📄 Package Label / Principal Display Panel 27 words ▾

Principal Display Panel Azelastine hydrochloride label Azelastine hydrochloride carton Azelastine hydrochloride insert Azelastine hydrochloride insert Azelastine hydrochloride label Azelastine hydrochloride carton Azelastine hydrochloride insert Azelastine hydrochloride insert

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

Over-the-counter (OTC) 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 Allegiant Health. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (69168-0478-63). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Allegiant Health 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 69168-0477-66 · Allegiant 69168-0479-64 · Allegiant →
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.