The short version
Just 2 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 and acetaminophen
butalbital and acetaminophen · BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 · Capsule · Oral · Granules Pharmaceuticals Inc.
NDC 70010-0054-05 · 500 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)
0.2%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 →
Where it's made
- Granules Pharmaceuticals Inc.United Statesanalysis · label · manufacture
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
- ANDA213115
- TE code
- AA
- Approval date
- Nov 22, 2019
- 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 (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Dr. Reddy's Labratories Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Granules Pharmaceuticals Inc. | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Dr. Reddy's Labratories Inc. | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Granules Pharmaceuticals Inc. | BUTALBITAL 300 mg/1; ACETAMINOPHEN 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Dr. Reddy's Labratories Inc. | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Granules Pharmaceuticals Inc. | 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, "butalbital and acetaminophen — NDC 70010-0054-05," retrieved September 3, 2026, https://drugdashboards.com/drug/70010005405.
Free to cite with attribution — see how the data is put together.