DrugDashboards

Formoterol Fumarate

formoterol fumarate dihydrate · FORMOTEROL FUMARATE 20 ug/2mL · Solution · Respiratory (Inhalation) · Mylan Pharmaceuticals Inc.

NDC 00378-1631-91 · 60 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL · NDA AUTHORIZED GENERIC · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble. The price has fallen 58% in a year, to $1.34 per mL — and generics that get this cheap tend to get abandoned rather than defended. 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)$1.34per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$1.55per billing unit (20 MCG)HCPCS J7606 · Jul 1, 2026
  • Part D plans paid (avg)$6.05per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$17.96per package of 60X2MLMylan Pharmaceuticals, Inc. · Jan 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 49502-0605-61) — 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
$10.05per unit
middle half $9.95$10.05 · 287 plans · Apr 1, 2026
Est. net of rebates
≈ $10.05
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
5%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 74%

*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$7.50Feb 2022Sep 2026$1.34
56 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$962.47
Reported to Texas DSHS · 2026 annual filing · Mylan Pharmaceuticals Inc.

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

Medicare Part B (ASP)

Payment limit per 20 MCG
$1.547
HCPCS J7606 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$213,192
1,304 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

15Low risk

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

  • price down 63% year over year+15

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 formoterol fumarate dihydrate (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
NDA022007
TE code
AN
Approval date
May 11, 2007
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of formoterol fumarate dihydrate (Solution)

LabelerStrengthFirst seenLast seen
Devatis, Inc.FORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCFORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.FORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Sep 2, 2026
NorthStar RxLLCFORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Sep 2, 2026
Ritedose Pharmaceuticals, LLCFORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Sep 2, 2026
Viatris Specialty LLCFORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Sep 2, 2026
Major PharmaceuticalsFORMOTEROL FUMARATE 20 ug/2mLJul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Formoterol Fumarate — NDC 00378-1631-91," retrieved September 3, 2026, https://drugdashboards.com/drug/00378163191.

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