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.
Acetaminophen and Codeine Phosphate
ACETAMINOPHEN and CODEINE PHOSPHATE · ACETAMINOPHEN 300 mg/12.5mL; CODEINE PHOSPHATE 30 mg/12.5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC 00121-1008-40 · 40 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE · 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.
Estimated fill cost
WAC per package, as filed
$349.32
Reported to Texas DSHS · 2026 annual filing · PAI Holdings LLC dba Pharmaceutical Associates, Inc. / PAI Pharma
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 acetaminophen and codeine phosphate (other) in the next 90 days
sole-source market · price up 4% YoY
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
- 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
- ANDA087508
- TE code
- —
- Approval date
- Jan 1, 1982
- 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 ACETAMINOPHEN and CODEINE PHOSPHATE (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| PAI Holdings, LLC dba PAI Pharma | ACETAMINOPHEN 120 mg/5mL; CODEINE PHOSPHATE 12 mg/5mL | Aug 13, 2026 | Sep 3, 2026 |
| PAI Holdings, LLC dba PAI Pharma | ACETAMINOPHEN 300 mg/12.5mL; CODEINE PHOSPHATE 30 mg/12.5mL | Jul 15, 2026 | Sep 3, 2026 |
| Genus Lifesciences Inc. | ACETAMINOPHEN 120 mg/5mL; CODEINE PHOSPHATE 12 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Acetaminophen and Codeine Phosphate — NDC 00121-1008-40," retrieved September 3, 2026, https://drugdashboards.com/drug/00121100840.
Free to cite with attribution — see how the data is put together.