DrugDashboards

Midazolam hydrochloride

Midazolam hydrochloride · MIDAZOLAM HYDROCHLORIDE 1 mg/mL · Injection, Solution · Intramuscular; Intravenous · Gland Pharma Limited

NDC 68083-0106-01 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply. It is in shortage right now — FDA lists the reason as “demand increase for the drug”.

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 midazolam hydrochloride (injectable) in the next 90 days

sterile injectable · sole-source market · price up 3% YoY

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
ANDA090696
TE code
AP
Approval date
Feb 29, 2012
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Midazolam Hydrochloride Preservative Free, Injection, 10 mg/2 mL (5 mg/mL) (NDC 0409-2308-02)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2 mL (NDC 76045-211-20)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2mL (1 mg/mL) (NDC 0409-2305-17)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride Preservative Free, Injection, 5 mg/5 mL (1 mg/mL) (NDC 0409-2305-05)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride Preservative Free, Injection, 5 mg/mL (5 mg/mL) (NDC 0409-2308-01)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 23155-600-41)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 25021-655-02)Apr 2, 2020
    Other
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-10)Apr 2, 2020
    Delay in shipping of the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-12)Apr 2, 2020
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-411-25)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 10 mg/10 mL (1 mg/mL) (NDC 0409-2587-05)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 25 mg/5 mL (5 mg/mL) (NDC 0409-2596-03)Apr 2, 2020
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 23155-601-41)Apr 2, 2020
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 23155-601-42)Apr 2, 2020
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 25021-661-10)Apr 2, 2020
    Other
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-02)Apr 2, 2020
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-10)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 5 mg/1 mL (NDC 63323-412-25)Apr 2, 2020
    Demand increase for the drug
    month 78 — 4× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Midazolam Hydrochloride, Injection, 50 mg/10 mL (5 mg/mL) (NDC 0409-2596-05)Apr 2, 2020
    month 78 — 4× 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 Midazolam hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Onesource Specialty Pharma LimitedMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 3, 2026
A-S Medication SolutionsMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
A-S Medication SolutionsMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Belcher Pharmaceuticals, LLCMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.MIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.MIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.MIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Jvet Pharmaceuticals LLCMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Remedyrepack Inc.MIDAZOLAM HYDROCHLORIDE 2 mg/2mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LlcMIDAZOLAM HYDROCHLORIDE 5 mg/5mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LlcMIDAZOLAM HYDROCHLORIDE 2 mg/2mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LlcMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Steriscience Specialties Private LimitedMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Steriscience Specialties Private LimitedMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Onesource Specialty Pharma LimitedMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Aug 31, 2026
Sagent PharmaceuticalsMIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Aug 31, 2026
Fresenius Kabi USA, LLCMIDAZOLAM HYDROCHLORIDE 2 mg/2mLJul 15, 2026Aug 29, 2026
Fresenius Kabi USA, LLCMIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 28, 2026
Hospira, Inc.MIDAZOLAM HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 28, 2026
Hospira, Inc.MIDAZOLAM HYDROCHLORIDE 1 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Midazolam hydrochloride — NDC 68083-0106-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083010601.

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