PillRx only · Solution/ Drops · Intraocular
Azelastine Hydrochloride
Azelastine Hydrochloride
5 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US5 NDCs
5 active makers
5 active makers
UKComing
soon
soon
CAComing
soon
soon
AUComing
soon
soon
EUComing
soon
soon
US acquisition costNADAC · per unit
Average across 4 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
$0.943
Latest avg · Jul 22, 2026
-2%
Since Dec 17, 2025
5
Active US suppliers
40%
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.
87K
Rx · 2026 Q1
554K
Units dispensed
-23%
Rx vs. year ago
5
Quarters · since 2025 Q1
Who makes it5 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Fosun Pharma USA Inc | unknown | 1 | SUPPLYING |
| Sandoz Inc | unknown | 1 | SUPPLYING |
| SUN PHARMACEUTICAL INDUSTRIES, INC. | unknown | 1 | SUPPLYING |
| Apotex Corp. | unknown | 1 | SUPPLYING |
| Gland Pharma Limited | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- May 28, 2025RECALLRecall (Class II): Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,…
Lack of Assurance of Sterility — Recalling firm: Apotex Corp. — US Nationwide.