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.
Codeine Sulfate
Codeine Sulfate · CODEINE SULFATE 15 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC 00527-1727-91 · 4 BLISTER PACK in 1 CARTON / 25 TABLET in 1 BLISTER PACK · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00054-0243-24) — 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ⓘ
$0.7248per unit
middle half $0.7024–$0.7248 · 1,182 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.7248
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
22%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 83%
*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 10 quarters since 2024.
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 codeine sulfate (oral solid) 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 →
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 · avg $65.82 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Opioid Analgesic REMS Shared System REMS
Regulatory
- Application
- ANDA203046
- TE code
- AB
- Approval date
- Jun 13, 2014
- 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 Codeine Sulfate (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | CODEINE SULFATE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | CODEINE SULFATE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | CODEINE SULFATE 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | CODEINE SULFATE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | CODEINE SULFATE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | CODEINE SULFATE 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Codeine Sulfate — NDC 00527-1727-91," retrieved September 3, 2026, https://drugdashboards.com/drug/00527172791.
Free to cite with attribution — see how the data is put together.