Budesonide, Glycopyrrolate and Formoterol Fumarate

Budesonide, Glycopyrrolate and Formoterol Fumarate · BUDESONIDE 160 ug/1; GLYCOPYRROLATE 9 ug/1; FORMOTEROL FUMARATE 4.8 ug/1 · Aerosol, Metered · Bespak HC Limited

NDC 12516-4616-01 · 320 POUCH in 1 BOX / 160 INHALER in 1 POUCH / 120 AEROSOL, METERED in 1 INHALER · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for budesonide, glycopyrrolate, and formoterol fumarate (other) in the next 90 days

sole-source market · price up 3% YoY

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: —
TE code: —
Approval date: —
Patents / exclusivity: —

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, Glycopyrrolate and Formoterol Fumarate (Aerosol, Metered)

Labeler	Strength	First seen	Last seen
Bespak HC Limited	BUDESONIDE 160 ug/1; GLYCOPYRROLATE 9 ug/1; FORMOTEROL FUMARATE 4.8 ug/1	Aug 20, 2026	Sep 3, 2026
Bespak HC Limited	BUDESONIDE 160 ug/1; GLYCOPYRROLATE 4.8 ug/1; FORMOTEROL FUMARATE 9 ug/1	Jul 22, 2026	Aug 19, 2026
Bespak HC Limited	BUDESONIDE 160 ug/1; FORMOTEROL FUMARATE 4.8 ug/1; GLYCOPYRROLATE 9 ug/1	Jul 15, 2026	Jul 15, 2026

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

Cite this page

DrugDashboards, "Budesonide, Glycopyrrolate and Formoterol Fumarate — NDC 12516-4616-01," retrieved September 3, 2026, https://drugdashboards.com/drug/12516461601.

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