Azelastine Hydrochloride 205.5 ug Spray, Metered
by Walgreens · 2 BOTTLE, SPRAY in 1 CARTON (0363-0653-05) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
NDC 00363-0653-05
🏷️ FDA NDC (as labeled)
0363-0653-05
billing pads the labeler segment with a zero
This package
Contains120 spray, metered in 1 bottle, spray
Pack sizes4 compare ↓
OTC
Generic
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
0363-0653-05
Product NDC
0363-0653
11-digit billing NDC
00363065305
RxCUI
1797883
UNII
0L591QR10I
UPC
0311917042343
Application #
ANDA216421
SPL Set ID
ec268981-433f-b26b-4ff0-3a121e0a0d08
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
2025-07-01
Route
NASAL
Dosage form
SPRAY, METERED
Substance
AZELASTINE HYDROCHLORIDE
GCN Seq No
065577
GCN
27584
HICL code
007607
Ingredient (HICL)
Azelastine Hcl
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q7
Therapeutic class — intermediate (HIC2)
Nasal Preparations
HIC3 code
Q7E
Therapeutic class — specific (HIC3)
Nasal Antihistamine
AHFS code
04:08.00.00
AHFS class
Second Generation Antihistamines
FDB label name
AZELASTINE 0.15% NASAL SPRAY
FDB brand name
Azelastine Hcl
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0363-0653-05 — a 4-4-2 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 labeler segment → 00363-0653-05. 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.
🏭 Manufacturer & labeler
LabelerWalgreens
Application holderAPOTEX INC
FDA applicationANDA216421 (ANDA)
Labeler code00363
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio342 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 0.15% NASAL SPRAY Ingredient Azelastine Hcl
📗 Our plain-language guide HelloPharmacist
- It treats two types of nasal conditions. The first is seasonal allergic rhinitis — that's hay fever, where your nose runs, you sneeze, and you feel congested because of allergens l...
- What exactly does azelastine nasal spray treat?
- It can, yes — drowsiness is one of the more common side effects. This is especially important to know before you drive or operate any machinery. Alcohol, sedatives, and tranquilize...
- That bitter taste is very common with azelastine — it's just how the medication tastes, and it's not a sign anything's wrong. A simple trick: tilt your head slightly downward while...
Patient education
Supplement & herbal interactions
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.
💬 Questions about Azelastine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 system | Per mL | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 ugthis 00363-0653-05 | Walgreens | 2 bottles | — | — | 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 ug 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
Jul 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.
🔬 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
Age at onset
Reporter sex
Male · 31%
Female · 68%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00363-0653-02 | 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) | 2025-07-01 | Active |
| 00363-0653-03 | 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01) | 2025-07-01 | Active |
| 00363-0653-04 | 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-04) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) | 2025-07-01 | Active |
| 00363-0653-05 You're viewing this | 2 BOTTLE, SPRAY in 1 CARTON (0363-0653-05) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-07-01 | Active |
Pack size FAQ
What quantity is in NDC 00363-0653-05?
NDC 00363-0653-05 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?
Bill NDC 00363-0653-05 — the 11-digit billing format is 00363065305. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 FDA registers it as 0363-0653-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00363-0653-05, written without dashes as 00363065305. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00363-0653-05, the first segment (00363) is the labeler code FDA assigned to Walgreens; the middle segment (0653) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Walgreens. 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 3 other package presentations of this same product, including 1 bottle (00363-0653-03), 1 bottle (00363-0653-04), 120 sprays (00363-0653-02). 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?
Walgreens 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.
📄 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
🎯 Indications and Usage ▾
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sneezing runny nose itchy nose
⏱️ Dosage and Administration ▾
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 sprays in 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 sprays in each nostril in a 24 hour period children under 6 years do not use
⚠️ Warnings ▾
Warnings Only for use in the nose. Do not spray in eyes or mouth. Do not use 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 breast-feeding, 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 (1-800-222-1222) right away.
🧪 Active Ingredient ▾
Active ingredient (in each spray) Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose
🎯 Purpose ▾
Purpose Antihistamine
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.