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Azelastine Hydrochloride 137 ug Spray, Metered — NDC 60505-0833-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Azelastine Hydrochloride 137 ug Spray, Metered — NDC 60505-0833-5 (Billing 60505-0833-05)

by Apotex Corp. · 1 BOTTLE, SPRAY in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE, SPRAY

This is a package of Azelastine Hydrochloride 137 ug Spray, Metered from Apotex Corp., marketed since Mar 2010 and currently FDA-listed; retail pharmacies pay about $0.2728 per mL (NADAC). It is this product's only package size.

NDC 60505-0833-05
🏷️ FDA NDC (as labeled) 60505-0833-5 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 60505-0833-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60505 labeler · 0833 product · 5 package
Package marketed since
Mar 1, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6050508335 0
Medicaid fills, this package
297,940 prescriptions in the last four reported quarters
FDA record last changed
Sep 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) 60505-0833-5
Product NDC 60505-0833
11-digit billing NDC 60505083305
NCPDP billing unit ML — per mL (volume)
RxCUI 1797867
UNII 0L591QR10I
Application # ANDA077954
SPL Set ID 4f58c203-f649-a18e-aaf3-70b0797652f4
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 2010-03-01
Route NASAL
Dosage form SPRAY, METERED
Substance AZELASTINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 029893
GCN 60544
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 0.1% (137 MCG) SPRY
FDB brand name Azelastine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 029893
  • GCN: 60544
  • HICL (First Databank): 007607
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1797867
Why two NDCs? The FDA registers this code as 60505-0833-5 — a 5-4-1 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 package segment → 60505-0833-05. 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.

Clinical

Label name AZELASTINE 0.1% (137 MCG) SPRY Ingredient Azelastine Hcl
📖 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 $0.273 —
Medicaid paysCMS SDUD · 12 mo $0.5636 —
Medicare drug plans payPart D · Q2 2026 $0.4445 —
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.314 $0.264
▲ Up 1% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60505-0833-05 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE, SPRAY 2010-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Azelastine Hydrochloride 137 ug 59651-0214-30 Aurobindo 1 bottle $0.273 AB Availability likely —
Azelastine Hydrochloride 137 ugthis 60505-0833-05 Apotex 1 bottle $0.273 AB Availability likely —
Azelastine Hydrochloride 1 mg/mL 65162-0676-84 Amneal 1 bottle $0.273 AB Availability likely —
Azelastine 137 ug 67877-0477-50 Ascend 1 spray $0.273 AB Availability likely —
Azelastine Hydrochloride 137 ug 72603-0611-01 NorthStar 1 bottle $0.273 AB Availability likely —
Azelastine Hydrochloride 137 ug 47335-0779-91 Sun 1 bottle $0.290 — FDA listed +6%
Azelastine Hydrochloride 1 mg/mL 42291-0094-30 AvKARE 1 bottle — AB FDA listed —
Azelastine Hydrochloride 137 ug 50090-2330-00 A-S 1 bottle — AB FDA listed —
Azelastine Hydrochloride 137 ug 50090-7461-00 A-S 1 bottle — AB FDA listed —
Azelastine Hydrochloride 137 ug 68788-4056-02 Preferred 1 bottle — AB FDA listed —
Azelastine Hydrochloride 137 ug 68788-8514-02 Preferred 1 bottle — AB FDA listed —
Azelastine Hydrochloride 137 ug 71205-0449-30 Proficient 1 bottle — AB 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

🏛️
2010
On the market since
Mar 2010
📍
2026
Currently FDA-listed
16 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 Nasal Spray 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • 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.

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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA077954 (ANDA)
Labeler code60505
First marketedMar 2010
Product typeHuman Prescription Drug
Portfolio306 products on file

More NDCs from Apotex Corp. labeler code 60505

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 98 words ▾

1 INDICATIONS AND USAGE Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION For intranasal use only ( 2.3 ) Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily ( 2.1 ) Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily ( 2.1 ) Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older ( 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 The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of azelastine hydrochloride nasal spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

2.2Vasomotor Rhinitis The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two 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 4 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 51 words ▾

3 DOSAGE FORMS AND STRENGTHS Azelastine hydrochloride nasal spray is a nasal spray solution. Each spray of azelastine hydrochloride nasal spray delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. Azelastine hydrochloride nasal spray: 137 mcg of azelastine hydrochloride in each 0.137 mL spray. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions 163 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 nasal spray. ( 5.1 ) Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine hydrochloride nasal spray because further decreased alertness and impairment of CNS performance may occur. ( 5.1 )

5.1Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine hydrochloride nasal spray [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 nasal spray. Concurrent use of azelastine hydrochloride nasal spray 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 nasal spray has been associated with somnolence [see Warnings and Precautions ( 5.1 )]. The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex CORP. at 1-800-706-5575 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. Seasonal Allergic Rhinitis Azelastine hydrochloride nasal spray Two Sprays Per Nostril Twice Daily Adverse experience information for azelastine hydrochloride nasal spray is derived from six placebo- and active- controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis who received azelastine hydrochloride nasal spray at a dose of 2 sprays per nostril twice daily.

In placebo-controlled efficacy trials, the incidence of discontinuation due to adverse reactions in patients receiving azelastine hydrochloride nasal spray and vehicle placebo was 2.2% and 2.8%, respectively. Table 1 contains adverse reactions that were reported with frequencies ≥2% in the azelastine hydrochloride nasal spray 2 sprays per nostril twice daily treatment group and more frequently than placebo. Table 1: Adverse Reactions Reported in ≥2% Incidence in Placebo-Controlled Trials in Patients with Seasonal Allergic Rhinitis [n (%)] Azelastine hydrochloride Nasal Spray N = 391 Vehicle Placebo N = 353 Bitter Taste 77 (19.7%) 2 (0.6%) Headache 58 (14.8%) 45 (12.7%) Somnolence 45 (11.5%) 19 (5.4%) Nasal Burning 16 (4.1%) 6 (1.7%) Pharyngitis 15 (3.8%) 10 (2.8%) Paroxysmal Sneezing 12 (3.1%) 4 (1.1%) Dry Mouth 11 (2.8%) 6 (1.7%) Nausea 11 (2.8%) 4 (1.1%) Rhinitis 9 (2.3%) 5 (1.4%) Fatigue 9 (2.3%) 5 (1.4%) Dizziness 8 (2.0%) 5 (1.4%) Epistaxis 8 (2.0%) 5 (1.4%) Weight Increase 8 (2.0%) 0 (0.0%) Azelastine hydrochloride nasal spray One Spray Per Nostril Twice Daily Adverse experience information for azelastine hydrochloride nasal spray at a dose of one spray per nostril twice daily is derived from two placebo-controlled 2-week clinical studies which included 276 patients 12 years of age and older with seasonal allergic rhinitis.

The incidence of discontinuation due to adverse reactions in patients receiving azelastine hydrochloride nasal spray and vehicle placebo was 0.0% and 0.8%, respectively. Bitter taste was reported in 8.3% of patients compared to none in the placebo group. Somnolence was reported in 0.4% of patients compared to none in the placebo group.

A total of 176 patients 5 to 11 years of age were exposed to azelastine hydrochloride nasal spray at a dose of 1 spray each nostril twice daily in 3 placebo-controlled studies. In these studies, adverse reactions that occurred more frequently in patients treated with azelastine hydrochloride nasal spray than with placebo, and that were not represented in the adult adverse reactions table above include rhinitis/cold symptoms (17.0% vs. 9.5%), cough (11.4% vs.

8.3%), conjunctivitis (5.1% vs. 1.8%), and asthma (4.5% vs. 4.1%).

Adverse Reactions <2% in azelastine hydrochloride nasal spray One or Two Sprays Per Nostril Twice Daily The following reactions were observed infrequently (<2% and exceeding placebo incidence) in patients who received azelastine hydrochloride nasal spray dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials. Cardiovascular Flushing, hypertension, tachycardia. Dermatological Contact dermatitis, eczema, hair and follicle infection, furunculosis, skin laceration.

Digestive Constipation, gastroenteritis, glossitis… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 46 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 )].

👥 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 nasal spray 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 5 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 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096 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 2-4% and 15-20%, 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 300 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m2 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 15 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 270 times the MRHDID in adults (on a mg/m 2 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 610 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 20 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 530 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 5 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 270 times the MRHDID (on mg/m2 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. Breastfed infants should be monitored for signs of milk rejection during azelastine hydrochloride use by lactating women (see Clinical Considerations). The developmental and health b… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 124 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 reactions, other than increased somnolence, since one bottle of azelastine hydrochloride nasal spray contains 30 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 reactions.

General supportive measures should be employed if overdosage occurs. There is no known antidote to azelastine hydrochloride nasal spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young 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 H1-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine hydrochloride nasal spray 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 H1-receptor antagonist activity.

12.2Pharmacodynamics Cardiac Electrophysiology In a placebo-controlled study (95 subjects 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.

These drugs had no effect on QTc based on analysis of serial electrocardiograms. At a dose approximately 8 times the maximum recommended dose, azelastine hydrochloride does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Absorption After intranasal administration, the systemic bioavailability of azelastine hydrochloride is approximately 40%. Maximum plasma concentrations (C max ) are achieved in 2­-3 hours. Azelastine hydrochloride administered intranasally at doses above two sprays per nostril twice daily for 29 days resulted in greater than proportional increases in C max and area under the curve (AUC) for azelastine.

Distribution Based on intravenous and oral administration, the steady-state volume of distribution 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 intranasal dosing of azelastine hydrochloride to steady-state, plasma concentrations of desmethylazelastine range from 20 to 50% of azelastine concentrations. Limited data indicate that the metabolite profile is similar when azelastine hydrochloride is administered via the intranasal or oral route.

Elimination Based on intravenous and oral administration, the elimination half-life and plasma clearance are 22 hours 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. 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 normal 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 No significant pharmacokinetic interaction was observed with the co­-administration of orally administered azelastine (4 mg twice daily) with erythromycin (500 mg three times daily for 7 days).

In this study, co-administration of orally administered azelastine with erythromycin 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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 193 words ▾

16 HOW SUPPLIED/ STORAGE AND HANDLING Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 mcg/spray, (NDC 60505-0833-5) is supplied as a package containing 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. A leaflet of patient instructions is also provided. The spray pump unit consists of a nasal spray pump fitted with a safety clip and a plastic dust cover.

The Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 mcg/spray, bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. The bottle can deliver 200 metered sprays. Each spray delivers a mean of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.

The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays 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 "EXP" printed on the medicine label and carton.

Storage Store upright at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle tightly closed and away from children.

📋 Description 189 words ▾

11 DESCRIPTION Azelastine hydrochloride nasal solution 0.1% (nasal spray), 137 micrograms (mcg) per spray, is an antihistamine 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 g/mol .

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 225ºC 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 nasal solution contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration ( 2.3 )] , each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base).

The bottle can deliver 200 metered sprays.

💬 Information for Patients ~1 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 Instruct patients to 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, which include bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase [ 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. APOTEX INC. AZELASTINE HYDROCHLORIDE NASAL SPRAY 137 mcg Manufactured in Canada for Apotex Corp, Weston, FL 33326 Revised: November 2021

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Seasonal Allergic Rhinitis Two Sprays Per Nostril Twice Daily The efficacy and safety of azelastine hydrochloride nasal spray were evaluated in three placebo-controlled clinical trials of azelastine hydrochloride nasal spray including 322 patients with seasonal allergic rhinitis who received two sprays per nostril twice a day for up to 4 weeks. These trials included 55 pediatric patients ages 12 to 16 years. Assessment of efficacy was based on the 12-hour reflective Total Symptom Complex (TSC) and Major Symptom Complex (MSC).

The MSC was calculated as the average of individual symptoms of nose blows, sneezes, runny nose/sniffles, itchy nose, and watery eyes as assessed by patients on a 0 to 5 categorical scale. Azelastine hydrochloride nasal spray two sprays per nostril twice daily demonstrated a greater decrease in the MSC than placebo (Table 3). Table 3: Mean Change from Baseline in Reflective MSC* in Adults and Adolescents ≥12 Years with Seasonal Allergic Rhinitis Treated with Azelastine hydrochloride Nasal Spray Two Sprays Per Nostril Twice Daily Versus Placebo Treatment N Baseline LS Mean (SD) Change from Baseline (SD) Treatment Difference P-value Trial 1: 12 Hour AM and PM Reflective MSC Azelastine hydrochloride Nasal Spray 63 11.48 (4.13) -3.05 (3.51) 1.98 <0.01 Placebo Nasal Spray 60 10.84 (4.53) -1.07 (3.52) Trial 2: 12 Hour AM and PM Reflective MSC Azelastine hydrochloride Nasal Spray 63 12.50 (4.5) -4.10 (3.46) 2.03 <0.01 Placebo Nasal Spray 63 12.18 (4.64) -2.07 (4.01) Trial 3: 12 Hour AM and PM Reflective MSC Azelastine hydrochloride Nasal Spray 66 12.04 (4.03) -3.31 (3.74) 1.35

0.04Placebo Nasal Spray 66 11.66 (3.96) -1.96 (3.57) *Major Symptom Comlex (MSC): Average of individual symptoms of nose blows, sneezes, runny nose/sniffles, itchy nose, and watery eyes as assessed by patients on a 0 to 5 categorical scale. In dose-ranging trials, administration of azelastine hydrochloride nasal spray two sprays per nostril twice daily resulted in a statistically significant decrease in symptoms compared to saline placebo within 3 hours after initial dosing and persisted over the 12-hour dosing interval.

One Spray Per Nostril Twice Daily The efficacy and safety of azelastine hydrochloride nasal spray were evaluated in two placebo-controlled clinical trials of azelastine hydrochloride nasal spray including 275 patients with seasonal allergic rhinitis who received one spray per nostril twice a day for up to 2 weeks. Assessment of efficacy was based on the 12­-hour reflective Total Nasal Symptom Score [rTNSS]. rTNSS is calculated as the sum of the patients scoring of four individual nasal symptoms (runny nose, sneezing, itchy nose, and nasal congestion) as assessed by patients on a 0 to 3 categorical scale.

The primary efficacy endpoint was the change from Baseline to Day 14 in rTNSS. The mean change from baseline in rTNSS was greater in patients receiving azelastine hydrochloride nasal spray one spray per nostril twice daily than those receiving placebo (Table 4). Table 4: Mean Change from Baseline in Reflective TNSS* in Adults and Adolescents ≥12 years with Seasonal Allergic Rhinitis Treated with Azelastine hydrochloride Nasal Spray One Spray Per Nostril Twice Daily Versus Placebo Treatment N Baseline LS Mean (SD) Change from Baseline (SD) Treatment Difference P-value Trial 4: 12 Hour AM and PM Reflective TNSS Azelastine hydrochloride Nasal Spray 138 16.34 (4.22) -2.69 (4.79) 1.38

0.01Placebo Nasal Spray 141 17.21 (4.32) -1.31 (4.29) Trial 5: 12 Hour AM and PM Reflective TNSS Azelastine hydrochloride Nasal Spray 137 16.62 (4.20) -3.68 (4.16) 1.18

0.02Placebo Nasal Spray 136 16.84 (4.77) -2.50 (4.01) * Total Nasal Symptom Score (TNSS): Average of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestion as assessed by patients on a 0 to 3 categorical scale. Two-week studies comparing the efficacy (and safety) of azelastine hydrochloride nasal spray two sprays per nostril twice… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1C a rcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies in Crl:CD(SD)BR rats and NMRI mice were conducted to assess the carcinogenic potential of azelastine hydrochloride. No evidence of tumorigenicity was observed in rats at doses up to 30 mg/kg day (approximately 270 and 240 times the MRHDID for adults and children, respectively, on a mg/m2 basis). No evidence for tumorigenicity was observed in mice at doses up to 25 mg/kg (approximately 110 and 100 times the MRHDID for adults and children, respectively, on a mg/m2 basis).

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. There were no effects on male or female fertility and reproductive performance in male and female rats at oral doses up to 30 mg/kg (approximately 270 times the MRHDID in adults on a mg/m 2 basis). At 68.6 mg/kg (approximately 610 times the MRHDID on a mg/m 2 basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased.

The numbers of corpora lutea and implantations were decreased; however, pre-implantation loss was not increased.

13.1C a rcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies in Crl:CD(SD)BR rats and NMRI mice were conducted to assess the carcinogenic potential of azelastine hydrochloride. No evidence of tumorigenicity was observed in rats at doses up to 30 mg/kg day (approximately 270 and 240 times the MRHDID for adults and children, respectively, on a mg/m2 basis). No evidence for tumorigenicity was observed in mice at doses up to 25 mg/kg (approximately 110 and 100 times the MRHDID for adults and children, respectively, on a mg/m2 basis).

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. There were no effects on male or female fertility and reproductive performance in male and female rats at oral doses up to 30 mg/kg (approximately 270 times the MRHDID in adults on a mg/m 2 basis). At 68.6 mg/kg (approximately 610 times the MRHDID on a mg/m 2 basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased.

The numbers of corpora lutea and implantations were decreased; however, pre-implantation loss was not increased.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Azelastine hydrochloride (a-ZEL-as-teen) Nasal Spray 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 people age 5 and older and vasomotor rhinitis in people age 12 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 with seasonal allergic rhinitis under 5 years of age or in children with vasomotor rhinitis under 12 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 nasal spray 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. 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 hydrochloride nasal spray bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine. If you use too much or a child accidentally swallows azelastine hydrochloride nasal spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using azelastine hydrochloride nasal spray? Azelastine hydrochloride nasal spray can cause sleepiness: Do not drive, operate machinery, or do other dangerous activities until you know how azelastine hydrochloride nasal spray affects you. Do not drink alcohol or take other medicines that may cause you to feel sleepy while using azelastine hydrochloride nasal spray.

It may make your sleepiness worse. What are the possible side effects of azelastine hydrochloride nasal spray? The most common side effects of azelastine hydrochloride nasal spray include: unusual bitter taste headache sleepiness nose burning, pain or discomfort runny nose scratchy or sore throat nosebleeds inflammation or swelling of the sinuses sneezing nausea dry mouth fatigue dizziness weight increase Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of azelastine hydrochloride nasal spray. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1­ 800-FDA-1088. How should I store azelastine hydrochloride nasal spray? Store upright at 20ºC to 25ºC (68ºF to 77ºF) Do not freeze azelastine hydrochloride nasal spray.

Do not use azelastine hydrochloride nasal spray after the expiration date "EXP" on the medicine label and box. Keep azelastine hydrochloride nasal spray and all medicines out of reach of children. General information about the safe and effective use of azelastine hyd… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 23 words ▾

PRINCIPAL DISPLAY PANEL - LABEL APOTEX CORP . NDC 60505-0833-5 AZELASTINE HYDROCHLORIDE NASAL SOLUTION 0.1% (NASAL SOLUTION), 137 mcg/spray Rx only 30 mL

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
297.9K
Units reimbursed last 4 qtrs
9.1M
Gross reimbursed last 4 qtrs
$5.14M
Avg / prescription
$17.26
Avg / unit
$0.5636
Latest quarter Q1 2026
74.5KRx
Medicaid pays / mL
$0.5636
gross reimbursed
vs
NADAC / mL
$0.2728
acquisition cost
=
Spread
+$0.2908
+107% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 126,163 Rx Managed care · 171,777 Rx
State Medicaid map
Alaska: 16,200 units · 2,210 per 100k residents AK Maine: 9,750 units · 699 per 100k residents ME Washington: 54,914 units · 703 per 100k residents WA Idaho: 40,110 units · 2,042 per 100k residents ID Montana: 6,751 units · 596 per 100k residents MT North Dakota: 5,970 units · 762 per 100k residents ND Minnesota: 132,375 units · 2,307 per 100k residents MN Wisconsin: 151,770 units · 2,568 per 100k residents WI Michigan: 451,067 units · 4,494 per 100k residents MI New York: 1,294,530 units · 6,615 per 100k residents NY Vermont: 7,500 units · 1,159 per 100k residents VT New Hampshire: 10,230 units · 730 per 100k residents NH Oregon: 15,600 units · 369 per 100k residents OR Nevada: 60,030 units · 1,879 per 100k residents NV Wyoming: 4,020 units · 688 per 100k residents WY South Dakota: 9,272 units · 1,009 per 100k residents SD Iowa: 54,240 units · 1,691 per 100k residents IA Illinois: 436,470 units · 3,478 per 100k residents IL Indiana: 78,090 units · 1,138 per 100k residents IN Ohio: 336,774 units · 2,858 per 100k residents OH Pennsylvania: 238,820 units · 1,843 per 100k residents PA New Jersey: 295,846 units · 3,185 per 100k residents NJ Massachusetts: 94,171 units · 1,345 per 100k residents MA California: 1,063,501 units · 2,729 per 100k residents CA Utah: 16,620 units · 486 per 100k residents UT Colorado: 106,080 units · 1,805 per 100k residents CO Nebraska: 64,380 units · 3,255 per 100k residents NE Missouri: 254,100 units · 4,101 per 100k residents MO Kentucky: 404,010 units · 8,926 per 100k residents KY West Virginia: 135,000 units · 7,627 per 100k residents WV Virginia: 144,900 units · 1,662 per 100k residents VA Maryland: 139,123 units · 2,251 per 100k residents MD Connecticut: 92,970 units · 2,570 per 100k residents CT Rhode Island: 21,120 units · 1,929 per 100k residents RI Arizona: 141,450 units · 1,904 per 100k residents AZ New Mexico: 228,300 units · 10,799 per 100k residents NM Kansas: 32,370 units · 1,101 per 100k residents KS Arkansas: 113,880 units · 3,713 per 100k residents AR Tennessee: 237,014 units · 3,326 per 100k residents TN North Carolina: 334,830 units · 3,090 per 100k residents NC South Carolina: 77,850 units · 1,449 per 100k residents SC Delaware: 52,662 units · 5,108 per 100k residents DE Oklahoma: 83,100 units · 2,050 per 100k residents OK Louisiana: 589,861 units · 12,896 per 100k residents LA Mississippi: 69,901 units · 2,378 per 100k residents MS Alabama: 62,970 units · 1,233 per 100k residents AL Georgia: 161,124 units · 1,461 per 100k residents GA D.C.: 17,071 units · 2,514 per 100k residents DC Hawaii: 9,150 units · 638 per 100k residents HI Texas: 535,544 units · 1,756 per 100k residents TX Florida: 133,620 units · 591 per 100k residents FL
Units reimbursed · per 100k residents
36912,896
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 12,896 /100k
2 New Mexico 10,799 /100k
3 Kentucky 8,926 /100k
4 West Virginia 7,627 /100k
5 New York 6,615 /100k
6 Delaware 5,108 /100k
7 Michigan 4,494 /100k
8 Missouri 4,101 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 60505-0830-01 · Apotex 60505-0845-05 · Apotex →
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.