The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Butalbital, Acetaminophen, and Caffeine
Butalbital, Acetaminophen, and Caffeine · BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 · Capsule · Oral · AvKARE
NDC 42291-0181-01 · 100 CAPSULE in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 52544-0080-01) — 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ⓘ
$0.5304per unit
middle half $0.4900–$0.7097 · 23 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.5304
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 2 · prior auth 43% · step therapy 0% · qty limit 100%
*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 7 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$96.67
Reported to Texas DSHS · 2026 annual filing · AvKare
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
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 →
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
- ANDA040885
- TE code
- AA
- Approval date
- Nov 16, 2009
- 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| AvKARE | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Aug 31, 2026 |
| Actavis Pharma, Inc. | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 20, 2026 |
| AvKARE | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Sun Pharmaceutical Industries, Inc. | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Northstar Rx Llc | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Jul 22, 2026 |
| Actavis Pharma, Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Sun Pharmaceutical Industries, Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 16, 2026 | Jul 16, 2026 |
| AvKARE | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Northstar Rx Llc | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Taro Pharmaceuticals U.S.A., Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Butalbital, Acetaminophen, and Caffeine — NDC 42291-0181-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42291018101.
Free to cite with attribution — see how the data is put together.