DrugDashboards

Nalbuphine hydrochloride

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

NDC 70069-0661-10 · 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE · 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. 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.

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.

Estimated fill cost

WAC per package, as filed
$549.15
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%

Medicaid spend (2026 YTD · Q1)

$42
14 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 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
ANDA216049
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 70069-0661-10," retrieved September 3, 2026, https://drugdashboards.com/drug/70069066110.

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