DrugDashboards

Morphine Sulfate

Morphine Sulfate · MORPHINE SULFATE 15 mg/1 · Tablet, Film Coated, Extended Release · Oral · Lupin Pharmaceuticals,Inc.

NDC 43386-0540-01 · 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $0.1910 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Part D plans paid (avg)$0.5055per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.3222per TABweighted avg manufacturer price $0.1841 · Apr 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 42858-0801-01) — 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
$0.3829per unit
middle half $0.2815$0.4765 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.3829
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 3 · prior auth 34% · step therapy 0% · qty limit 96%

*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$0.1$0.2$0.3Mar 2017Mar 2022$0.191
61 price points · per · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: 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 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
ANDA203602
TE code
Approval date
Dec 16, 2015
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedApr 10, 2019
    LUPIN SOMERSETFailed Impurities/Degradation Specifications
  • Class III · TerminatedApr 10, 2019
    LUPIN SOMERSETFailed Impurities/Degradation Specifications
  • Class III · TerminatedApr 10, 2019
    LUPIN SOMERSETFailed Impurities/Degradation Specifications
  • Class III · TerminatedApr 10, 2019
    LUPIN SOMERSETFailed Impurities/Degradation Specifications
  • Class III · TerminatedApr 10, 2019
    LUPIN SOMERSETFailed Impurities/Degradation Specifications
  • Class III · TerminatedAug 23, 2018
    LUPIN SOMERSETFailed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.

Manufacturers of Morphine Sulfate (Tablet, Film Coated, Extended Release)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackMORPHINE SULFATE 200 mg/1Jul 15, 2026Sep 3, 2026
American Health PackagingMORPHINE SULFATE 15 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingMORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.MORPHINE SULFATE 200 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.MORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.MORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.MORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals,Inc.MORPHINE SULFATE 15 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMORPHINE SULFATE 15 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsMORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Rhodes Pharmaceuticals LLCMORPHINE SULFATE 200 mg/1Jul 15, 2026Sep 2, 2026
Rhodes Pharmaceuticals LLCMORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MORPHINE SULFATE 60 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MORPHINE SULFATE 100 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MORPHINE SULFATE 15 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MORPHINE SULFATE 200 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.MORPHINE SULFATE 30 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMORPHINE SULFATE 30 mg/1Jul 15, 2026Aug 31, 2026
Bryant Ranch PrepackMORPHINE SULFATE 15 mg/1Jul 15, 2026Aug 31, 2026
Bryant Ranch PrepackMORPHINE SULFATE 100 mg/1Jul 15, 2026Aug 31, 2026
Bryant Ranch PrepackMORPHINE SULFATE 60 mg/1Jul 15, 2026Aug 31, 2026
Rhodes Pharmaceuticals LLCMORPHINE SULFATE 60 mg/1Jul 15, 2026Aug 31, 2026
Rhodes Pharmaceuticals LLCMORPHINE SULFATE 15 mg/1Jul 15, 2026Aug 31, 2026
Rhodes Pharmaceuticals LLCMORPHINE SULFATE 30 mg/1Jul 15, 2026Aug 28, 2026
Actavis Pharma, Inc.MORPHINE SULFATE 30 mg/1Jul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Morphine Sulfate — NDC 43386-0540-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43386054001.

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