DrugDashboards

Budesonide Inhalation Suspension

Budesonide · BUDESONIDE 1 mg/2mL · Inhalant · Oral · Cipla USA Inc.

NDC 69097-0321-53 · 30 POUCH in 1 CARTON / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $3.65 per mL over the past year. 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)$3.65per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$1.09per billing unit (0.5 MG)HCPCS J7626 · Jul 1, 2026
  • Part D plans paid (avg)$1.28per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 69097-0321-87) — 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
$4.25per unit
middle half $3.57$5.58 · 3,500 plans · Apr 1, 2026
Est. net of rebates
≈ $4.25
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
64%of plans cover it
tier 4 · prior auth 100% · step therapy 0% · qty limit 32%

*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$2.00$4.00$6.00Oct 2020Sep 2026$3.65
72 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$300.00
Reported to Texas DSHS · 2025 annual filing · Cipla USA Inc.

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

Medicare Part B (ASP)

Payment limit per 0.5 MG
$1.092
HCPCS J7626 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$214,970
633 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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)

0.2%chance of a new FDA shortage posting for budesonide (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months

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
ANDA205710
TE code
AN
Approval date
Nov 16, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJun 30, 2025
    Cipla USA, Inc.Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
  • Class II · TerminatedSep 15, 2022
    CIPLALack of Assurance of Sterility

Manufacturers of Budesonide (Inhalant)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsBUDESONIDE .25 mg/2mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.BUDESONIDE .25 mg/2mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.BUDESONIDE .5 mg/2mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.BUDESONIDE 1 mg/2mLJul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals, Inc.BUDESONIDE 1 mg/2mLJul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals, Inc.BUDESONIDE .5 mg/2mLJul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals, Inc.BUDESONIDE .25 mg/2mLJul 15, 2026Sep 2, 2026
Nephron Pharmaceuticals CorporationBUDESONIDE .5 mg/2mLJul 15, 2026Sep 2, 2026
Nephron Pharmaceuticals CorporationBUDESONIDE .25 mg/2mLJul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.BUDESONIDE .5 mg/2mLJul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.BUDESONIDE .5 mg/2mLJul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.BUDESONIDE .25 mg/2mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Budesonide Inhalation Suspension — NDC 69097-0321-53," retrieved September 3, 2026, https://drugdashboards.com/drug/69097032153.

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