DrugDashboards

Ketamine Hydrochloride

Ketamine Hydrochloride · KETAMINE HYDROCHLORIDE 100 mg/mL · Injection, Solution · Intramuscular; Intravenous · Gland Pharma Limited

NDC 68083-0506-10 · 10 VIAL in 1 CARTON / 5 mL in 1 VIAL · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× 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.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for ketamine hydrochloride (injectable) in the next 90 days

sterile injectable · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 3× 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
ANDA216809
TE code
AP
Approval date
Jan 24, 2023
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 Ketamine Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Gland Pharma LimitedKETAMINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedKETAMINE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedKETAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsKETAMINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsKETAMINE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsKETAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Ketamine Hydrochloride — NDC 68083-0506-10," retrieved September 3, 2026, https://drugdashboards.com/drug/68083050610.

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