DrugDashboards

Butalbital And Acetaminophen

butalbital and acetaminophen · BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 · Tablet · Oral · Burel Pharmaceuticals, LLC

NDC 35573-0455-02 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble. The price has fallen 54% in a year, to $1.53 per unit — 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)$1.53per EAinvoice-surveyed acquisition cost · Dec 17, 2025
  • Medicaid generic ceiling (FUL)$2.38per TABweighted avg manufacturer price $1.3626 · Nov 1, 2025156% of what pharmacies pay — higher than 81% of drugs with this benchmark

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$2.00$4.00Apr 2024Dec 2025$1.53
22 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$45.97
#90 count
$137.91

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

Medicaid spend (2025)

$1,314
25 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 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 →

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
ANDA214088
TE code
AA
Approval date
Apr 7, 2022
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 (Tablet)

LabelerStrengthFirst seenLast seen
Par HealthBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 27, 2026Sep 3, 2026
Aarkish Pharmaceuticals NJ Inc.ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Sep 2, 2026
Amici Pharma, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 25 mg/1Jul 15, 2026Sep 2, 2026
Amici Pharma, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Sep 2, 2026
Amici Pharma, Inc.ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
El Dorado Distributors LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Larken Laboratories, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Larken Laboratories, Inc.BUTALBITAL 25 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 31, 2026
Endo USABUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 26, 2026
Larken Laboratories, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 25 mg/1Jul 22, 2026Aug 20, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Burel Pharmaceuticals, LLCBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
El Dorado Distributors LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Endo USABUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Larken Laboratories, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1Jul 22, 2026Aug 19, 2026
Larken Laboratories, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 25 mg/1Jul 15, 2026Jul 19, 2026
Burel Pharmaceuticals, LLCACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Burel Pharmaceuticals, LLCACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
El Dorado Distributors LLCACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Endo USAACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Larken Laboratories, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Quagen Pharmaceuticals LlcACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1Jul 15, 2026Jul 15, 2026
Quagen Pharmaceuticals LlcACETAMINOPHEN 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 35573-0455-02," retrieved September 3, 2026, https://drugdashboards.com/drug/35573045502.

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