DrugDashboards

Codeine Sulfate

Codeine Sulfate · CODEINE SULFATE 60 mg/1 · Tablet · Oral · Lannett Company, Inc.

NDC 00527-1699-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price has held steady around $1.06 per unit over the past year.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00054-0245-25) — 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
$1.43per unit
middle half $1.35$1.46 · 1,255 plans · Apr 1, 2026
Est. net of rebates
≈ $1.43
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
23%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 84%

*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

$0$0.5$1.00$1.50May 2015Mar 2021$1.06
15 price points · per · last surveyed Invalid DateSource: CMS NADAC

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)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.CODEINE SULFATE 15 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.CODEINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.CODEINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.CODEINE SULFATE 15 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.CODEINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.CODEINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Codeine Sulfate — NDC 00527-1699-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00527169901.

Free to cite with attribution — see how the data is put together.