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Azelastine Hydrochloride 1.5 mg/mL Spray, Metered

by Akorn · 1 BOTTLE, PUMP in 1 CARTON (50383-942-30) / 30 mL in 1 BOTTLE, PUMP
NDC 50383-0942-30
🏷️ FDA NDC (as labeled) 50383-942-30 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 50383-942-30
Product NDC 50383-942
11-digit billing NDC 50383094230
NCPDP billing unit ML — per mL (volume)
Application # ANDA210032
SPL Set ID fc69f672-17ec-4d86-b5af-086fd260b512
Established class (EPC) Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
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 F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50383-942-30 — 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 → 50383-0942-30. 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

LabelerAkorn
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA210032 (ANDA)
Labeler code50383
Product typeHuman Prescription Drug
Portfolio3 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

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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.831 $24.92 / 30 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Mar 2022 Jun 2022 Nov 2022 $0.933 $0.432
▲ Up 33% over the last 11 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 1.5 mg/mLthis 50383-0942-30 Akorn 1 bottle $0.831 — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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

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
50383-0942-30 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (50383-942-30) / 30 mL in 1 BOTTLE, PUMP 2019-08-27 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 50383-942-30, 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: 50383-0942-30, written without dashes as 50383094230. 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 50383-0942-30, the first segment (50383) is the labeler code FDA assigned to Akorn; the middle segment (0942) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Akorn 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.

📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 87 words ▾

1 INDICATIONS AND USAGE Azelastine hydrochloride nasal spray is an H 1 -receptor antagonist indicated for the relief of the symptoms of: • Seasonal allergic rhinitis in patients 6 years of age and older. (1.1) • Perennial allergic rhinitis in patients 6 years of age and older. (1.1).

1.1Allergic Rhinitis Azelastine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • For intranasal use only. (2.3) • Seasonal allergic rhinitis : • 6 to 11 years : Azelastine hydrochloride 0.15%: 1 spray per nostril twice daily. (2.1) • Adults and adolescents 12 years of age and older: ○ Azelastine hydrochloride 0.15%: 1 or 2 sprays per nostril twice daily (2.1), or ○ 2 sprays per nostril once daily.

(2.1) • Perennial allergic rhinitis : • 6 to 11 years: Azelastine hydrochloride 0.15%: 1 spray per nostril twice daily. (2.2) • Adults and adolescents 12 years of age and older: Azelastine hydrochloride 0.15%: 2 sprays per nostril twice daily. (2.2) • Prime azelastine hydrochloride nasal spray before initial use and when it has not been used for 3 or more days.

(2.3)

2.1Seasonal Allergic Rhinitis Children 6 to 11 years of age: Azelastine hydrochloride nasal spray, 0.15%, 1 spray per nostril twice daily. Adults and adolescents 12 years of age and older: Azelastine hydrochloride nasal spray, 0.15%, 1 or 2 sprays per nostril twice daily. Azelastine hydrochloride nasal spray 0.15% may also be administered as 2 sprays per nostril once daily.

2.2Perennial Allergic Rhinitis Children 6 to 11 years of age: Azelastine hydrochloride nasal spray, 0.15%, 1 spray per nostril twice daily. Adults and adolescents 12 years of age and older: Azelastine hydrochloride nasal spray, 0.15%, 2 sprays per nostril twice daily.

2.3Important Administration Instructions Administer azelastine hydrochloride nasal spray by the intranasal route only. Priming: Prime azelastine hydrochloride nasal spray before initial use by releasing 6 sprays or until a fine mist appears. When azelastine hydrochloride nasal spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying azelastine hydrochloride nasal spray into the eyes.

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS Azelastine hydrochloride is a nasal solution: Each spray of azelastine hydrochloride nasal spray, 0.15% delivers a volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. Nasal spray solution available in one dosage strength: • Azelastine hydrochloride nasal spray, 0.15%: 205.5 mcg of azelastine hydrochloride in each 0.137 mL spray. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None. (4)

⚠️ Warnings and Cautions 148 words ▾

5 WARNINGS AND PRECAUTIONS • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride. (5.1) • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with azelastine hydrochloride because further decreased alertness and impairment of CNS performance may occur. (5.1)

5.1Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine hydrochloride [ see Adverse Reactions (6.1) ]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of azelastine hydrochloride. Concurrent use of azelastine hydrochloride with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [ see Drug Interactions (7.1) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Use of azelastine hydrochloride has been associated with somnolence [ see Warnings and Precautions (5.1) ]. The most common adverse reactions (≥2% incidence) are: pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Azelastine Hydrochloride Nasal Spray, 0.15% The safety data described below reflect exposure to azelastine hydrochloride nasal spray, 0.15% in 2114 patients (6 months of age and older) with season or perennial allergic rhinitis from 10 clinical trials of 2 weeks to 12 months duration.

In 8 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1703 patients (646 males and 1059 females) with seasonal or perennial allergic rhinitis were treated with azelastine hydrochloride 0.15% one or two sprays per nostril once or twice daily. In the 12 month open-label, active-controlled clinical trial, 466 patients (156 males and 310 females) with perennial allergic rhinitis were treated with azelastine hydrochloride 0.15% two sprays per nostril twice daily. Of these 466 patients, 152 had participated in the 4-week placebo-controlled perennial allergic rhinitis clinical trials.

In a 4-week, double-blind, placebo-controlled clinical trial, 161 patients (87 males and 74 females) ages 6 to 11 years of age with perennial allergic rhinitis, with or without concomitant seasonal allergic rhinitis, were treated with azelastine hydrochloride 0.15% one spray per nostril twice daily. In a 4-week clinical trial, 95 patients (59 males and 36 females) ages 6 months to 5 years of age with seasonal and/ or perennial allergic rhinitis were treated with azelastine hydrochloride 0.15% one spray per nostril twice daily.

The racial distribution for the 10 clinical trials was 79% white, 14% black, 2% Asian, and 5% other. Adults and Adolescents 12 Years of Age and Older In the 7 placebo controlled clinical trials of 2 to 4 week duration, 2343 patients with seasonal allergic rhinitis and 540 patients with perennial allergic rhinitis were treated with two sprays per nostril of either azelastine hydrochloride 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the azelastine hydrochloride 0.15% treatment groups (16 to 31%) than in the placebo groups (11 to 24%).

Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups. Table 3 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with azelastine hydrochloride 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials. Table 3.

Adverse Reactions with ≥2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks’ Duration with Azelastine Hydrochloride 0.15% in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis 2 Sprays Twice Daily 2 Sprays Once Daily Azelastine Hydrochloride 0.15% (N=523) Vehicle Placebo (N=523) Azelastine Hydrochloride 0.15% (N=1021) Vehicle Placebo (N=816) Bitter Taste 31 (6%) 5 (1%) 38 (4%) 2 (<1%) Nasal Discomfort 18 (3%) 12 (2%) 37 (4%) 7 (1%) Epistaxis 5 (1%) 7 (1%) 21 (2%) 14 (2%) Sneezing 9 (2%) 1 (<1%) 14 (1%) 0 (0%) In the above trials, somnolence was reported in <1% of patients treated with azelastine hydrochloride 0.15% (11 of 1544) or vehicle placebo (1 of 1339).

Long-Term (12 Month) Safety Trial : In the 12 month,…

🔄 Drug Interactions 168 words ▾

7 DRUG INTERACTIONS

7.1Central Nervous System Depressants Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [ see Warnings and Precautions (5.1) ].

7.2Erythromycin and Ketoconazole Interaction studies investigating the cardiac effects, as measured by the corrected QT interval (QTc), of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin (500 mg three times daily for 7 days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms. Ketoconazole (200 mg twice daily for 7 days) interfered with the measurement of azelastine plasma concentrations on the analytic HPLC; however, no effects on QTc were observed [ see Clinical Pharmacology (12.2 ) and (12.3) ].

7.3Cimetidine Cimetidine (400 mg twice daily) increased the mean C max and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65% [ see Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 4 times the clinical daily dose. Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 180 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.644 mg.

However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hydrochloride caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 200 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight.

Neither fetal nor maternal effects occurred in mice at approximately 9 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 3 mg/kg/day). In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hydrochloride caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 180 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day).

Azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 410 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/ kg/day). Neither fetal nor maternal effects occurred at approximately 10 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 2 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 360 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 30 mg/kg/day).

Neither fetal nor maternal effects occurred at approximately 4 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 0.3 mg/kg/day). In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hydrochloride produced no adverse developmental effects on pups at maternal doses up to approximately 180 times the MRHDID (on mg/m 2 basis at a maternal dose of 30 mg/kg/day).

8.2Lactation Risk Summary There are no data on the presence of azelastine hydrochloride in human milk, the effects on the breastfed infant, or the effects on milk production following use of azelastine hydrochloride. Because many drugs are excreted in human milk, caution should be exercised when azelastine hydrochloride is administered to a nursing woman. The…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 4 times the clinical daily dose. Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 180 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.644 mg.

However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hydrochloride caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 200 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight.

Neither fetal nor maternal effects occurred in mice at approximately 9 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 3 mg/kg/day). In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hydrochloride caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 180 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day).

Azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 410 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 68.6 mg/ kg/day). Neither fetal nor maternal effects occurred at approximately 10 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 2 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 360 times the MRHDID in adults (on a mg/m 2 basis at a maternal oral dose of 30 mg/kg/day).

Neither fetal nor maternal effects occurred at approximately 4 times the MRHDID (on a mg/m 2 basis at a maternal oral dose of 0.3 mg/kg/day). In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hydrochloride produced no adverse developmental effects on pups at maternal doses up to approximately 180 times the MRHDID (on mg/m 2 basis at a maternal dose of 30 mg/kg/day).

🧒 Pediatric Use 66 words ▾

8.4Pediatric Use The safety and effectiveness of azelastine hydrochloride 0.15% have been established for seasonal allergic rhinitis in pediatric patients 6 to 17 years of age and perennial allergic rhinitis in pediatric patients 6 to 17 years of age [ see Clinical Studies (14) ]. The safety and effectiveness of azelastine hydrochloride 0.15% in pediatric patients below 6 years of age have not been established.

🧓 Geriatric Use 86 words ▾

8.5Geriatric Use Clinical trials of azelastine hydrochloride did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 125 words ▾

10 OVERDOSAGE There have been no reported overdosages with azelastine hydrochloride nasal spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence, since one 30-mL bottle of azelastine hydrochloride nasal spray, 0.15% contains up to 45 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events.

General supportive measures should be employed if overdosage occurs. There is no known antidote to azelastine hydrochloride. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children.

Accordingly, azelastine hydrochloride nasal spray should be kept out of the reach of children.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H 1 -receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine hydrochloride is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H 1 -receptor antagonist activity.

12.2Pharmacodynamics Cardiac Effects: In a placebo-controlled trial (95 patients with allergic rhinitis), there was no evidence of an effect of azelastine hydrochloride nasal spray (2 sprays per nostril twice daily for 56 days) on cardiac repolarization as represented by the corrected QT interval (QTc) of the electrocardiogram. Following multiple dose oral administration of azelastine 4 mg or 8 mg twice daily, the mean change in QTc was 7.2 msec and 3.6 msec, respectively. Interaction studies investigating the cardiac repolarization effects of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted.

Oral erythromycin had no effect on azelastine pharmacokinetics or QTc based on analysis of serial electrocardiograms. Ketoconazole interfered with the measurement of azelastine plasma levels; however, no effects on QTc were observed [ see Drug Interactions (7.2) ].

12.3Pharmacokinetics Absorption: After intranasal administration of 2 sprays per nostril (822 mcg total dose) of azelastine hydrochloride 0.15%, the mean azelastine peak plasma concentration (C max ) is 409 pg/mL, the mean extent of systemic exposure (AUC) is 9312 pg•hr/mL and the median time to reach C max (t max ) is 4 hours. The systemic bioavailability of azelastine hydrochloride is approximately 40% after intranasal administration. Distribution: Based on intravenous and oral administration, the steady-state volume of distribution of azelastine is

14.5L/kg. In vitro studies with human plasma indicate that the plasma protein binding of azelastine and its metabolite, desmethylazelastine, are approximately 88% and 97%, respectively. Metabolism: Azelastine is oxidatively metabolized to the principal active metabolite, desmethylazelastine, by the cytochrome P450 enzyme system.

The specific P450 isoforms responsible for the biotransformation of azelastine have not been identified. After a single-dose, intranasal administration of azelastine hydrochloride 0.15% (822 mcg total dose), the mean desmethylazelastine C max is 38 pg/mL, the AUC is 3824 pg•hr/mL and the median t max is 24 hours. After intranasal dosing of azelastine to steady-state, plasma concentrations of desmethylazelastine range from 20 to 50% of azelastine concentrations.

Elimination: Following intranasal administration of azelastine hydrochloride 0.15%, the elimination half-life of azelastine is 25 hours while that of desmethylazelastine is 57 hours. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Special Populations: Hepatic Impairment: Following oral administration, pharmacokinetic parameters were not influenced by hepatic impairment.

Renal Impairment: Based on oral, single-dose studies, renal insufficiency (creatinine clearance <50 mL/min) resulted in a 70 to 75% higher C max and AUC compared to healthy subjects. Time to maximum concentration was unchanged. Age: Following oral administration, pharmacokinetic parameters were not influenced by age.

Gender: Following oral administration, pharmacokinetic parameters were not influenced by gender. Race: The effect of race has not been evaluated. Drug-Drug Interactions: Erythromycin: Co-administration of orally administered azelastine (4 mg twice daily) with erythromycin (500 mg three times daily for 7 days) resulted in C max of 5.36 ± 2.6 ng/mL and AUC of 49.7 ± 24 ng•h/mL for azelastine, whereas, administration of azelastine alone resulted in C max of 5.57 ± 2.7 ng/mL…

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H 1 -receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine hydrochloride is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H 1 -receptor antagonist activity.

📦 How Supplied / Storage and Handling 193 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Azelastine Hydrochloride 0.15% Nasal Spray is supplied as a 30-mL package (NDC 50383-942-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a clear plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution).

The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [ see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty.

The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage Store upright at controlled room temperature 20° to 25°C (68° to 77°F).

Protect from freezing.

📋 Description 181 words ▾

11 DESCRIPTION Azelastine Hydrochloride 0.15% Nasal Spray is an antihistamine (H 1 -receptor antagonist) formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37.

It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride.

Its molecular formula is C 22 H 24 ClN 3 O•HCl with the following chemical structure: Azelastine Hydrochloride 0.15% Nasal Spray contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4). After priming [ see Dosage and Administration (2.3) ], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base).

The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays. chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use). Activities Requiring Mental Alertness Somnolence has been reported in some patients taking azelastine hydrochloride nasal spray. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of azelastine hydrochloride nasal spray [ see Warnings and Precautions (5.1) ].

Concurrent Use of Alcohol and other Central Nervous System Depressants Avoid concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur [ see Warnings and Precautions (5.1) ]. Common Adverse Reactions Inform patients that the treatment with azelastine hydrochloride nasal spray may lead to adverse reactions, most common of which include pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain [ see Adverse Reactions (6.1) ].

Priming Instruct patients to prime the pump before initial use and when azelastine hydrochloride nasal spray has not been used for 3 or more days [ see Dosage and Administration (2.3) ]. Keep Spray Out of Eyes Instruct patients to avoid spraying azelastine hydrochloride nasal spray into their eyes. Keep Out of Children’s Reach Instruct patients to keep azelastine hydrochloride nasal spray out of the reach of children.

If a child accidentally ingests azelastine hydrochloride nasal spray, seek medical help or call a poison control center immediately. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev.942:01 01/20 PATIENT INFORMATION Azelastine Hydrochloride Nasal Spray, 0.15% (a zel’ as teen) Important: For use in your nose only.

What is Azelastine Hydrochloride Nasal Spray? • Azelastine Hydrochloride Nasal Spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in patients 6 years of age and older and year-round allergic rhinitis in people age 6 years and older. • Azelastine Hydrochloride Nasal Spray may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing. It is not known if Azelastine Hydrochloride Nasal Spray is safe and effective in children under 6 years of age. What should I tell my healthcare provider before using Azelastine Hydrochloride Nasal Spray?

Before using Azelastine Hydrochloride Nasal Spray, tell your healthcare provider if you are: • allergic to any of the ingredients in Azelastine Hydrochloride Nasal Spray. See the end of this leaflet for a complete list of ingredients in Azelastine Hydrochloride Nasal Spray. • pregnant, or plan to become pregnant. • breastfeeding, or plan to breastfeed. It is not known if Azelastine Hydrochloride passes into your breast milk.

You and your healthcare provider should decide if you will use Azelastine Hydrochloride Nasal Spray if you plan to breastfeed. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Azelastine Hydrochloride Nasal Spray and other medicines may affect each other, causing side effects.

How should I use Azelastine Hydrochloride Nasal Spray? • Read the Instructions for Use at the end of this leaflet for information about the right way to use Azelastine Hydrochloride Nasal Spray. • An adult should help a young child use Azelastine Hydrochloride Nasal Spray. • Spray Azelastine Hydrochloride Nasal Spray in your nose only . Do not spray it into your eyes or mouth. • Use Azelastine Hydrochloride Nasal Spray exactly as your healthcare provider tells you to use it. • Do not use more than your healthcare provider tells you. • Throw away your Azelastine Hydroch…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50383-0913-40 · Akorn 50384-0100-01 · Sterling →
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.