Hydromorphone Hydrochloride

Hydromorphone Hydrochloride · HYDROMORPHONE HYDROCHLORIDE 2 mg/mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Fresenius Kabi USA, LLC

NDC 63323-0853-25 · 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. The brand price has held steady around $2.74 per mL over the past year. It is in shortage right now — FDA lists the reason as “other”. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built

Data sources

CMS NADAC (pharmacy acquisition, weekly)
CMS Part B ASP quarterly payment limits
CMS Maximum Fair Prices (IRA negotiated, NDC-level)
Medicare Part D Spending by Drug (data.cms.gov, name-matched)
VA FSS / Big4 federal contract prices (va.gov, twice monthly)
ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
California SB-17 WAC filings (list price, per package)

Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

Pharmacies pay (NADAC)$2.74per MLinvoice-surveyed acquisition cost · Jul 22, 2026
Medicare Part B pays (ASP+6%)$0.1360per billing unit (0.1 MG)HCPCS J1171 · Jul 1, 2026
Federal ceiling (Big4)$8.22per package of 25X1MLFresenius Kabi, LLC · Jan 1, 2026

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

15 price points · per ML · held since Jul 22, 2026Source: CMS NADAC

Estimated fill cost

WAC per package, as filed

$108.00

Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 0.1 MG

$0.136

HCPCS J1171 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$34,238

4,425 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

40● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

5 active manufacturers+5
in shortage now+25
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 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 →

Where it's made

Fresenius Kabi USA, LLCUnited States
analysis · manufacture

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 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: NDA019034
TE code: AP
Approval date: Jan 11, 1984
Patents / exclusivity: 14 patents, 0 exclusivities

Type	Number / code	Expires
patent	9248229	Mar 12, 2034
patent	9248229	Mar 12, 2034
patent	9248229	Mar 12, 2034
patent	9248229	Mar 12, 2034
patent	9248229	Mar 12, 2034
patent	9248229	Mar 12, 2034
patent	9248229	Mar 12, 2034
patent	9731082	Apr 23, 2032
patent	9731082	Apr 23, 2032
patent	9731082	Apr 23, 2032
patent	9731082	Apr 23, 2032
patent	9731082	Apr 23, 2032

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)

Labeler	Strength	First seen	Last seen
Fresenius Kabi USA, LLC	HYDROMORPHONE HYDROCHLORIDE 1 mg/mL	Jul 15, 2026	Sep 3, 2026
Fresenius Kabi USA, LLC	HYDROMORPHONE HYDROCHLORIDE 2 mg/mL	Jul 15, 2026	Sep 3, 2026
Teva Parenteral Medicines, Inc.	HYDROMORPHONE HYDROCHLORIDE 10 mg/mL	Jul 15, 2026	Sep 3, 2026
Bond Pharmacy INC	HYDROMORPHONE HYDROCHLORIDE 100 mg/mL	Jul 15, 2026	Sep 2, 2026
Fresenius Kabi USA, LLC	HYDROMORPHONE HYDROCHLORIDE 4 mg/mL	Jul 15, 2026	Sep 2, 2026
Fresenius Kabi USA, LLC	HYDROMORPHONE HYDROCHLORIDE 10 mg/mL	Jul 15, 2026	Sep 2, 2026
Fresenius Kabi USA, LLC	HYDROMORPHONE HYDROCHLORIDE .2 mg/mL	Jul 15, 2026	Sep 2, 2026
Hikma Pharmaceuticals USA Inc.	HYDROMORPHONE HYDROCHLORIDE 2 mg/mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	HYDROMORPHONE HYDROCHLORIDE 4 mg/mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	HYDROMORPHONE HYDROCHLORIDE .25 mg/.5mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	HYDROMORPHONE HYDROCHLORIDE .5 mg/.5mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	HYDROMORPHONE HYDROCHLORIDE 1 mg/mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	HYDROMORPHONE HYDROCHLORIDE 10 mg/mL	Jul 15, 2026	Sep 2, 2026
Hospira, Inc.	HYDROMORPHONE HYDROCHLORIDE 2 mg/mL	Jul 15, 2026	Aug 28, 2026

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

Cite this page

DrugDashboards, "Hydromorphone Hydrochloride — NDC 63323-0853-25," retrieved September 3, 2026, https://drugdashboards.com/drug/63323085325.

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