DrugDashboards

Diphenhydramine

diphenhydramine hydrochloride · DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL · Injection, Solution · Intramuscular; Intravenous · Avenacy, LLC

NDC 83634-0781-01 · 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble. 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 0.4% 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

$0$0.5$1.00Aug 2026Sep 2026$0.9336
2 price points · per MLSource: CMS NADAC

Supply fragility

10● Low risk

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

  • 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)

0.4%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
ANDA205336
TE code
AP
Approval date
Jun 24, 2025
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, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
HF Acquisition Co LLC, DBA HealthFirstDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Micro Labs LimitedDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Armas Pharmaceuticals Inc.DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Avenacy, LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionDIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsDIPHENHYDRAMINE 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, "Diphenhydramine — NDC 83634-0781-01," retrieved September 3, 2026, https://drugdashboards.com/drug/83634078101.

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