DrugDashboards

Butalbital, Acetaminophen, Caffeine

Butalbital, Acetaminophen, and Caffeine · BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC

NDC 80425-0570-01 · 30 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

17 companies supply this market — deep enough that no single failure threatens the supply.

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

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00527-1695-05) — 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ⓘ
$0.2817per unit
middle half $0.1932–$0.3372 · 2,917 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.2817
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
53%of plans cover it
tier 3 · prior auth 15% · step therapy 0% · qty limit 90%

*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

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 butalbital, acetaminophen and caffeine (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
ANDA209587
TE code
AA
Approval date
Oct 31, 2018
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, Acetaminophen, and Caffeine (Tablet)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Actavis Pharma, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Advanced Rx of Tennessee, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Asclemed USA, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
AvPAKBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Cardinal Health 107, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Hawaii Repack, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Lannett Company, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Lgm Pharma Solutions, LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Major PharmaceuticalsBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Strides Pharma Science LimitedBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Westminster Pharmaceuticals, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Bryant Ranch PrepackBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Aug 31, 2026
Proficient Rx LPBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Aug 31, 2026
Remedyrepack Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Aug 28, 2026
Bryant Ranch PrepackBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 22, 2026
Proficient Rx LPBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 22, 2026
A-S Medication SolutionsBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Actavis Pharma, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Advanced Rx of Tennessee, LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Asclemed USA, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
AvPAKBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Cardinal Health 107, LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Hawaii Repack, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Lannett Company, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Lgm Pharma Solutions, LlcBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Major PharmaceuticalsBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Preferred Pharmaceuticals Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Remedyrepack Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Strides Pharma Science LimitedBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Westminster Pharmaceuticals, LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
American Health PackagingBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Jul 29, 2026
Bryant Ranch PrepackACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 19, 2026
Proficient Rx LPACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 19, 2026
Remedyrepack Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 19, 2026
A-S Medication SolutionsACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Actavis Pharma, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Advanced Rx of Tennessee, LLCACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Butalbital, Acetaminophen, Caffeine — NDC 80425-0570-01," retrieved September 3, 2026, https://drugdashboards.com/drug/80425057001.

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