DrugDashboards

Morphine Sulfate

morphine sulfate · MORPHINE SULFATE 100 mg/1 · Capsule, Extended Release · Oral · Nortec Development Associates, Inc.

NDC 42689-0010-01 · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

4 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00832-0233-00) — 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ⓘ
$13.57per unit
middle half $8.55–$15.80 · 91 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $13.57
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
2%of plans cover it
tier 4 · prior auth 1% · step therapy 12% · qty limit 74%

*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 morphine sulfate (oral solid) in the next 90 days

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

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 · avg $28.78 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA203158
TE code
—
Approval date
Aug 4, 2021
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 morphine sulfate (Capsule, Extended Release)

LabelerStrengthFirst seenLast seen
Actavis Pharma, Inc.MORPHINE SULFATE 90 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.MORPHINE SULFATE 120 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.MORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.MORPHINE SULFATE 45 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.MORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.MORPHINE SULFATE 75 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 80 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 50 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 20 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCMORPHINE SULFATE 40 mg/1Jul 15, 2026Sep 2, 2026
Nortec Development Associates, Inc.MORPHINE SULFATE 20 mg/1Jul 15, 2026Sep 2, 2026
Nortec Development Associates, Inc.MORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Nortec Development Associates, Inc.MORPHINE SULFATE 80 mg/1Jul 15, 2026Sep 2, 2026
Nortec Development Associates, Inc.MORPHINE SULFATE 50 mg/1Jul 15, 2026Sep 2, 2026
Nortec Development Associates, Inc.MORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Nortec Development Associates, Inc.MORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 10 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 20 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 80 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMORPHINE SULFATE 50 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Morphine Sulfate — NDC 42689-0010-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42689001001.

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