Pillstats
Rx only · Spray, Metered · Nasal

Azelastine Hydrochloride

Azelastine Hydrochloride

12 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US15 NDCs
12 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)18603
US makers12 labelers
Packages26
DEA / ScheduleNone

US acquisition costNADAC · per unit

Average across 4 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.

$0.083$0.167$0.250$0.333Dec 2025Apr 2026Jul 2026
$0.282
Latest avg · Jul 22, 2026
-1%
Since Dec 17, 2025
12
Active US suppliers
35%
Top-2 supplier share*

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

130K260K390K520K2025 Q12025 Q22025 Q32025 Q42026 Q1
430K
Rx · 2026 Q1
12.9M
Units dispensed
+2%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it12 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
CVS Pharmacyunknown5SUPPLYING
WALGREEN COMPANYunknown4SUPPLYING
Allegiant Healthunknown3SUPPLYING
Aurohealth LLCunknown3SUPPLYING
YYBA Corpunknown2SUPPLYING
Preferred Pharmaceuticals Inc.unknown2SUPPLYING
A-S Medication Solutionsunknown2SUPPLYING
Apotex Corp.unknown1SUPPLYING
SUN PHARMACEUTICAL INDUSTRIES, INC.unknown1SUPPLYING
Aurobindo Pharma Limitedunknown1SUPPLYING
Proficient Rx LPunknown1SUPPLYING
NorthStar Rx LLCunknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Feb 5, 2018
    RECALLRecall (Class III): Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutica…

    Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station — Recalling firm: Sun Pharmaceutical Industries, Inc. — Nationwide

  • Jun 15, 2011
    RECALLRecall (Class III): Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., T…

    CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. — Recalling firm: Apotex Corp. — Nationwide and Puerto Rico