DrugDashboards

Budesonide and formoterol fumarate dihydrate

Budesonide and formoterol fumarate dihydrate · BUDESONIDE 160 ug/1; FORMOTEROL FUMARATE 4.5 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Teva Pharmaceuticals, Inc.

NDC 00480-3081-31 · 1 POUCH in 1 CARTON / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$10.00$20.00Jun 2026Sep 2026$17.47
3 price points · per GMSource: CMS NADAC

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

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 budesonide and 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
ANDA212212
TE code
AB
Approval date
Apr 23, 2026
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 Budesonide and formoterol fumarate dihydrate (Aerosol, Metered)

LabelerStrengthFirst seenLast seen
Teva Pharmaceuticals, Inc.BUDESONIDE 160 ug/1; FORMOTEROL FUMARATE 4.5 ug/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.BUDESONIDE 80 ug/1; FORMOTEROL FUMARATE 4.5 ug/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Budesonide and formoterol fumarate dihydrate — NDC 00480-3081-31," retrieved September 3, 2026, https://drugdashboards.com/drug/00480308131.

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