DrugDashboards

Diphenhydramine Hydrochloride

diphenhydramine hydrochloride · DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL · Injection · Intramuscular; Intravenous · Sportpharm LLC

NDC 85766-0253-25 · 25 VIAL in 1 PACKAGE / 1 mL in 1 VIAL · ANDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply. 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 diphenhydramine hydrochloride (injectable) in the next 90 days

sterile injectable · sole-source market · price up 5% 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 →

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
ANDA080817
TE code
AP
Approval date
Jan 1, 1982
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 diphenhydramine hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsDIPHENHYDRAMINE HCL 50 mg/mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Remedyrepack Inc.DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Cardinal Health 107, LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co. LLC, DBA Health FirstDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Micro Labs LimitedDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Sportpharm LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 25, 2026Aug 29, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Diphenhydramine Hydrochloride — NDC 85766-0253-25," retrieved September 3, 2026, https://drugdashboards.com/drug/85766025325.

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