DrugDashboards

Morphine Sulfate

Morphine Sulfate · MORPHINE SULFATE 1 mg/30mL · Injection · Intravenous · International Medication Systems, Limited

NDC 76329-1912-01 · 10 VIAL in 1 PACKAGE / 30 mL in 1 VIAL · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. It is in shortage right now — FDA lists the reason as “demand increase for the drug”. One of its named manufacturing plants, International Medication Systems, Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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
  • Federal contracts pay (FSS)$100.50per package of 10X30MLAmphastar Pharmaceuticals, Inc. · Mar 15, 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

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)

0.5%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 →

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 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
ANDA202861
TE code
—
Approval date
Apr 29, 2021
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 25% 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 25% 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 25% 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 25% 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 25% 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 25% 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 25% 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 25% 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 76329-1912-01," retrieved September 3, 2026, https://drugdashboards.com/drug/76329191201.

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