The short version
8 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Allzital
butalbital and acetaminophen · BUTALBITAL 25 mg/1; ACETAMINOPHEN 325 mg/1 · Tablet · Oral · Larken Laboratories, Inc.
NDC 68047-0752-01 · 100 TABLET 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)
0.2%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
- ANDA203484
- TE code
- AA
- Approval date
- Dec 4, 2015
- 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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Par Health | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 27, 2026 | Sep 3, 2026 |
| Aarkish Pharmaceuticals NJ Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amici Pharma, Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amici Pharma, Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amici Pharma, Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Burel Pharmaceuticals, LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Burel Pharmaceuticals, LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| El Dorado Distributors LLC | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Larken Laboratories, Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Larken Laboratories, Inc. | BUTALBITAL 25 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Aug 31, 2026 |
| Endo USA | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Aug 26, 2026 |
| Larken Laboratories, Inc. | BUTALBITAL 325 mg/1; ACETAMINOPHEN 25 mg/1 | Jul 22, 2026 | Aug 20, 2026 |
| Burel Pharmaceuticals, LLC | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Burel Pharmaceuticals, LLC | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| El Dorado Distributors LLC | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Endo USA | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Larken Laboratories, Inc. | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Quagen Pharmaceuticals Llc | BUTALBITAL 325 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Larken Laboratories, Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 25 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Burel Pharmaceuticals, LLC | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Burel Pharmaceuticals, LLC | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| El Dorado Distributors LLC | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Endo USA | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Larken Laboratories, Inc. | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Quagen Pharmaceuticals Llc | ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Quagen Pharmaceuticals Llc | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 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, "Allzital — NDC 68047-0752-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68047075201.
Free to cite with attribution — see how the data is put together.