DrugDashboards

Nalbuphine hydrochloride

Nalbuphine hydrochloride · NALBUPHINE HYDROCHLORIDE 10 mg/mL · Injection · Intramuscular; Intravenous; Subcutaneous · Somerset Therapeutics, LLC

NDC 70069-0671-10 · 10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 4× the typical drug (0.1%).

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)$4.32per MLinvoice-surveyed acquisition cost · Mar 18, 2026
  • Medicare Part B pays (ASP+6%)$4.29per billing unit (10 MG)HCPCS J2300 · Jul 1, 2026

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$2.00$4.00$6.00Dec 2025Sep 2026$4.32
4 price points · per ML · held since Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$61.87
Reported to Texas DSHS · 2026 annual filing · Somerset Therapeutics, LLC

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

Medicare Part B (ASP)

Payment limit per 10 MG
$4.287
HCPCS J2300 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

20Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10
  • 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 nalbuphine hydrochloride (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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA216050
TE code
AP
Approval date
Sep 19, 2024
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 Nalbuphine hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Somerset Therapeutics, LLCNALBUPHINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 3, 2026
Henry Schein, Inc.NALBUPHINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.NALBUPHINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCNALBUPHINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCNALBUPHINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Nalbuphine hydrochloride — NDC 70069-0671-10," retrieved September 3, 2026, https://drugdashboards.com/drug/70069067110.

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