DrugDashboards

Morphine Sulfate

Morphine Sulfate · MORPHINE SULFATE 4 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00641-6125-25 · 25 VIAL, SINGLE-DOSE in 1 PACKAGE / 1 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $2.31 per mL over the past year. It is in shortage right now — FDA lists the reason as “demand increase for the drug”. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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.

  • Pharmacies pay (NADAC)$2.31per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$8.09per billing unit (10 MG)HCPCS J2270 · Jul 1, 2026
  • Part D plans paid (avg)$0.5055per dosage unitgross, before rebates — matched by drug name · 2024

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

$0$1.00$2.00$3.00Apr 2024Sep 2026$2.31
16 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$62.43
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 10 MG
$8.087
HCPCS J2270 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$353,677
65,906 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

40● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 4 active manufacturers+5
  • in shortage now+25
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for morphine sulfate (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 4× that.

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 2 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
ANDA205758
TE code
AP
Approval date
May 21, 2015
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Morphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1)Dec 6, 2018
    month 93 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Duramorph, Injection, .5 mg/1 mL (NDC 0641-6020-10)Nov 3, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Duramorph, Injection, 1 mg/1 mL (NDC 0641-6019-10)Nov 3, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Morphine Sulfate, Injection, 10 mg/1 mL (NDC 0641-6127-25)Nov 3, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Morphine Sulfate, Injection, 4 mg/1 mL (NDC 0641-6125-25)Nov 3, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Morphine Sulfate, Injection, 8 mg/1 mL (NDC 0641-6126-25)Nov 3, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Mitigo, Injection, 200 mg/20 mL (NDC 66794-160-02)Oct 31, 2017
    Demand increase for the drug
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Mitigo, Injection, 500 mg/20 mL (NDC 66794-162-02)Oct 31, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Morphine Sulfate (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.MORPHINE SULFATE 4 mg/mLJul 15, 2026Sep 3, 2026
Civica, Inc.MORPHINE SULFATE 4 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MORPHINE SULFATE 10 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MORPHINE SULFATE 2 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MORPHINE SULFATE .5 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MORPHINE SULFATE 1 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MORPHINE SULFATE 8 mg/mLJul 15, 2026Sep 2, 2026
International Medication Systems, LimitedMORPHINE SULFATE 1 mg/30mLJul 15, 2026Sep 2, 2026
Piramal Critical Care, Inc.MORPHINE SULFATE 500 mg/20mLJul 15, 2026Sep 2, 2026
Piramal Critical Care, Inc.MORPHINE SULFATE 200 mg/20mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Morphine Sulfate — NDC 00641-6125-25," retrieved September 3, 2026, https://drugdashboards.com/drug/00641612525.

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