DrugDashboards

Butalbital and Acetaminophen

Butalbital and Acetaminophen tablets · BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 · Tablet · Oral · Oceanside Pharmaceuticals

NDC 68682-0306-01 · 100 TABLET in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has fallen 48% in a year, to $1.58 per unit — and generics that get this cheap tend to get abandoned rather than defended. 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.

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)$1.58per EAinvoice-surveyed acquisition cost · Sep 17, 2025
  • Part D point of sale (median)$4.41per unitnegotiated price across 22 plans — before rebates · Jul 1, 2024
  • Medicaid generic ceiling (FUL)$2.38per TABweighted avg manufacturer price $1.3626 · Nov 1, 2025151% of what pharmacies pay — higher than 81% of drugs with this benchmark

Medicare Part D

All Part D pricing →
ⓘ 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
$4.41per unit
middle half $4.31$4.72 · 22 plans · Jul 1, 2024
Est. net of rebates
≈ $4.41
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
of plans cover it

*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 3 quarters since 2024.

NADAC price per unit

$0$5.00$10.00$15.00Oct 2017Sep 2025$1.58
21 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$47.38
#90 count
$142.14

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$894,116
2,354 prescriptions paid by Medicaid nationally · all Medicaid spend →

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)

0.2%chance of a new FDA shortage posting for butalbital and acetaminophen (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · 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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA090956
TE code
AA
Approval date
Aug 23, 2011
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 Butalbital and Acetaminophen tablets (Tablet)

LabelerStrengthFirst seenLast seen
Oceanside PharmaceuticalsBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Oceanside PharmaceuticalsBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Oceanside PharmaceuticalsACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Butalbital and Acetaminophen — NDC 68682-0306-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68682030601.

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