DrugDashboards

Butalbital, Acetaminophen And Caffeine

butalbital, acetaminophen and caffeine · ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg/1 · Capsule · Oral · Sunrise Pharmaceutical, Inc

NDC 11534-0187-04 · 500 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. The price is down 27% over the past year, to $0.3980 per unit.

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 11534-0187-01) — 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ⓘ
$0.6441per unit
middle half $0.5372–$0.7653 · 470 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.6441
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
9%of plans cover it
tier 3 · prior auth 68% · step therapy 0% · qty limit 97%

*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$1.00$2.00$3.00Jul 2017Jul 2024$0.398
85 price points · per · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

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
ANDA207118
TE code
AA
Approval date
Oct 28, 2016
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 (Capsule)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg/1Aug 26, 2026Sep 3, 2026
Advanced Rx of Tennessee, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Amici Pharma, Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Dr. Reddy's Labratories Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Granules Pharmaceuticals Inc.BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 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
Mayne PharmaBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Seton Pharmaceuticals LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Seton Pharmaceuticals LLCBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Solco Healthcare Us, LlcBUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1Aug 26, 2026Sep 2, 2026
Sunrise Pharmaceutical, IncACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg/1Aug 26, 2026Sep 2, 2026
Bryant Ranch PrepackBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 22, 2026
Bryant Ranch PrepackACETAMINOPHEN 300 mg/1; CAFFEINE 50 mg/1; BUTALBITAL 40 mg/1Jul 22, 2026Aug 21, 2026
Advanced Rx of Tennessee, LLCBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Amici Pharma, Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Aurolife Pharma, LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Dr. Reddy's Labratories Inc.BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Granules Pharmaceuticals Inc.BUTALBITAL 300 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
Mayne PharmaBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Quagen Pharmaceuticals LlcBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Seton Pharmaceuticals LLCBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Seton Pharmaceuticals LLCBUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Solco Healthcare Us, LlcBUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1Jul 22, 2026Aug 19, 2026
Sunrise Pharmaceutical, IncACETAMINOPHEN 300 mg/1; CAFFEINE 50 mg/1; BUTALBITAL 40 mg/1Jul 22, 2026Aug 19, 2026
Bryant Ranch PrepackACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 19, 2026
Bryant Ranch PrepackACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 19, 2026
Advanced Rx of Tennessee, LLCACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Amici Pharma, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Aurolife Pharma, LLCACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Dr. Reddy's Labratories Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Granules Pharmaceuticals Inc.ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Lannett Company, Inc.ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Mayne PharmaACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1Jul 15, 2026Jul 15, 2026
Quagen Pharmaceuticals LlcACETAMINOPHEN 300 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 And Caffeine — NDC 11534-0187-04," retrieved September 3, 2026, https://drugdashboards.com/drug/11534018704.

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