DrugDashboards

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride · HYDROMORPHONE HYDROCHLORIDE 2 mg/mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Hikma Pharmaceuticals USA Inc.

NDC 00641-6254-01 · 1 VIAL in 1 CARTON / 20 mL in 1 VIAL · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. It is in shortage right now — FDA lists the reason as “other”.

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 hydromorphone 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 →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
NDA217812
TE code
—
Approval date
Dec 14, 2023
Patents / exclusivity
1 patents, 0 exclusivities
TypeNumber / codeExpires
patent12653820Jan 10, 2043

Shortage history

  • In shortage now — Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11)Nov 1, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11)Nov 1, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 0.25 mg/ 0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-1805-01)Nov 1, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 0.5 mg/0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-4264-01)Nov 1, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0018-01)Nov 1, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0110-03)Nov 1, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0113-03)Nov 1, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-6254-01)Nov 1, 2017
    Demand increase for the drug
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 4 mg/1 mL (NDC 63323-854-10)Nov 1, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-06)Oct 31, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-11)Oct 31, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 0409-1283-37)Oct 31, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-852-25)Oct 31, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 1 mg/1 mL Syringes (NDC 0409-1283-31)Oct 31, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0409-2634-01)Oct 31, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-10)Oct 31, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-15)Oct 31, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-50)Oct 31, 2017
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-1312-36)Oct 31, 2017
    Other
    month 107 — 5× the typical 20-month injectable shortage · model puts 25% odds it resolves within 6 months
  • In shortage now — Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-3365-10)Oct 31, 2017
    month 107 — 5× 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 Hydromorphone Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCHYDROMORPHONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCHYDROMORPHONE HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Teva Parenteral Medicines, Inc.HYDROMORPHONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 3, 2026
Bond Pharmacy INCHYDROMORPHONE HYDROCHLORIDE 100 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCHYDROMORPHONE HYDROCHLORIDE 4 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCHYDROMORPHONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCHYDROMORPHONE HYDROCHLORIDE .2 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.HYDROMORPHONE HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.HYDROMORPHONE HYDROCHLORIDE 4 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.HYDROMORPHONE HYDROCHLORIDE .25 mg/.5mLJul 15, 2026Sep 2, 2026
Hospira, Inc.HYDROMORPHONE HYDROCHLORIDE .5 mg/.5mLJul 15, 2026Sep 2, 2026
Hospira, Inc.HYDROMORPHONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.HYDROMORPHONE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.HYDROMORPHONE HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Hydromorphone Hydrochloride — NDC 00641-6254-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00641625401.

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