DrugDashboards

hydromorphone hydrochloride

hydromorphone hydrochloride · HYDROMORPHONE HYDROCHLORIDE 12 mg/1 · Tablet, Extended Release · Oral · XLCare Pharmaceuticals, Inc.

NDC 72865-0169-01 · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 13811-0702-10) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$7.10per unit
middle half $6.15–$8.67 · 184 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $7.10
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
3%of plans cover it
tier 4 · prior auth 55% · step therapy 0% · qty limit 89%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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)

0.1%chance of a new FDA shortage posting for hydromorphone hydrochloride (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

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 · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA212133
TE code
AB
Approval date
Sep 23, 2020
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 hydromorphone hydrochloride (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
Camber Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 16 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 12 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 32 mg/1Jul 15, 2026Sep 2, 2026
Padagis US LLCHYDROMORPHONE HYDROCHLORIDE 12 mg/1Jul 15, 2026Sep 2, 2026
Padagis US LLCHYDROMORPHONE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
Padagis US LLCHYDROMORPHONE HYDROCHLORIDE 16 mg/1Jul 15, 2026Sep 2, 2026
Padagis US LLCHYDROMORPHONE HYDROCHLORIDE 32 mg/1Jul 15, 2026Sep 2, 2026
Trigen Laboratories, LLCHYDROMORPHONE HYDROCHLORIDE 12 mg/1Jul 15, 2026Sep 2, 2026
Trigen Laboratories, LLCHYDROMORPHONE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
Trigen Laboratories, LLCHYDROMORPHONE HYDROCHLORIDE 32 mg/1Jul 15, 2026Sep 2, 2026
Trigen Laboratories, LLCHYDROMORPHONE HYDROCHLORIDE 16 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 16 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 32 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.HYDROMORPHONE HYDROCHLORIDE 12 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "hydromorphone hydrochloride — NDC 72865-0169-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72865016901.

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