DrugDashboards

Azelastine Hydrochloride and Fluticasone Propionate

Azelastine Hydrochloride and Fluticasone Propionate · AZELASTINE HYDROCHLORIDE 137 ug/1; FLUTICASONE PROPIONATE 50 ug/1 · Spray, Metered · Nasal · Mylan Pharmaceuticals Inc.

NDC 00378-3458-23 · 1 BOTTLE in 1 BOX / 120 SPRAY, METERED in 1 BOTTLE · NDA AUTHORIZED GENERIC · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. The generic price has fallen 33% in a year, to $2.19 per gram — and generics that get this cheap tend to get abandoned rather than defended. The brand (Dymista) runs $9.14 per gram 4.2× more. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$2.19per GMinvoice-surveyed acquisition cost · Aug 19, 2026
  • Federal ceiling (Big4)$87.98per package of 23GMMylan Pharmaceuticals, Inc. · Jan 1, 2026
  • Medicaid generic ceiling (FUL)$2.19per GMweighted avg manufacturer price $0.9258 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 60505-0953-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$4.29per unit
middle half $3.94$5.39 · 227 plans · Apr 1, 2026
Est. net of rebates
≈ $4.29
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
4%of plans cover it
tier 4 · prior auth 0% · step therapy 9% · qty limit 96%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$2.50$5.00$7.50Jun 2020Sep 2026$2.19
76 price points · per GM · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

WAC per package, as filed
$170.84
Reported to Texas DSHS · 2026 annual filing · Mylan Pharmaceuticals Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$6,338
81 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

23Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 4 active manufacturers+5
  • price down 32% year over year+8
  • manufacturer plans to discontinue+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for azelastine hydrochloride and fluticasone propionate (other) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Regulatory

Application
NDA202236
TE code
AB
Approval date
May 1, 2012
Patents / exclusivity
2 patents, 0 exclusivities
TypeNumber / codeExpires
patent8168620*PEDAug 24, 2026
patent8168620Feb 24, 2026

Shortage history

  • Planned discontinuation Azelastine Hydrochloride; Fluticasone Propionate, Nasal Spray, 137 ug; 50 ug (NDC 0378-3458-23)Sep 4, 2025

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Azelastine Hydrochloride and Fluticasone Propionate (Spray, Metered)

LabelerStrengthFirst seenLast seen
Apotex Corp.AZELASTINE HYDROCHLORIDE 137 ug/1; FLUTICASONE PROPIONATE 50 ug/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AZELASTINE HYDROCHLORIDE 137 ug/1; FLUTICASONE PROPIONATE 50 ug/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.AZELASTINE HYDROCHLORIDE 137 ug/1; FLUTICASONE PROPIONATE 50 ug/1Jul 15, 2026Sep 2, 2026
Viatris Specialty LLCAZELASTINE HYDROCHLORIDE 137 ug/1; FLUTICASONE PROPIONATE 50 ug/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Azelastine Hydrochloride and Fluticasone Propionate — NDC 00378-3458-23," retrieved September 3, 2026, https://drugdashboards.com/drug/00378345823.

Free to cite with attribution — see how the data is put together.