The short version
12 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.
Butalbital, Acetaminophen And Caffeine
butalbital, acetaminophen and caffeine · BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 · Capsule · Oral · Seton Pharmaceuticals LLC
NDC 13925-0535-01 · 100 CAPSULE in 1 BOTTLE · ANDA · View full market →
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
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 →
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
- ANDA214087
- TE code
- AA
- Approval date
- Aug 13, 2021
- 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 |
|---|---|---|---|
| Bryant Ranch Prepack | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Advanced Rx of Tennessee, LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Amici Pharma, Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurolife Pharma, LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Dr. Reddy's Labratories Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Granules Pharmaceuticals Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Mayne Pharma | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Seton Pharmaceuticals LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Seton Pharmaceuticals LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Solco Healthcare Us, Llc | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Sunrise Pharmaceutical, Inc | ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 22, 2026 |
| Bryant Ranch Prepack | ACETAMINOPHEN 300 mg/1; CAFFEINE 50 mg/1; BUTALBITAL 40 mg/1 | Jul 22, 2026 | Aug 21, 2026 |
| Advanced Rx of Tennessee, LLC | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Amici Pharma, Inc. | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Aurolife Pharma, LLC | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Dr. Reddy's Labratories Inc. | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Granules Pharmaceuticals Inc. | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Lannett Company, Inc. | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Mayne Pharma | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Seton Pharmaceuticals LLC | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Seton Pharmaceuticals LLC | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Solco Healthcare Us, Llc | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1; CAFFEINE 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Sunrise Pharmaceutical, Inc | ACETAMINOPHEN 300 mg/1; CAFFEINE 50 mg/1; BUTALBITAL 40 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Bryant Ranch Prepack | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Bryant Ranch Prepack | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Advanced Rx of Tennessee, LLC | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Amici Pharma, Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Aurolife Pharma, LLC | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Dr. Reddy's Labratories Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Granules Pharmaceuticals Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Lannett Company, Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Mayne Pharma | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Quagen Pharmaceuticals Llc | 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 13925-0535-01," retrieved September 3, 2026, https://drugdashboards.com/drug/13925053501.
Free to cite with attribution — see how the data is put together.