Hydromorphone Hydrochloride

Hydromorphone Hydrochloride · HYDROMORPHONE HYDROCHLORIDE 10 mg/mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Teva Parenteral Medicines, Inc.

NDC 00703-0110-03 · 10 VIAL in 1 CARTON / 1 mL in 1 VIAL · ANDA · 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

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00409-2634-01) — 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ⓘ

$3.56per unit

middle half $3.56–$51.79 · 1,722 plans · Apr 1, 2026

Est. net of rebatesⓘ

≈ $3.56

generic — rebates are minimal, so net ≈ gross

Coverage & restrictions

31%of plans cover it

tier 4 · prior auth 16% · step therapy 0% · qty limit 2%

*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.

Estimated fill cost

WAC per package, as filed

$34.90

Reported to Texas DSHS · 2026 annual filing · Teva Parenteral Medicines, Inc.

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)

$379

13 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 →

Where it's made

Hospira, Inc.United States
analysis · label · manufacture · pack

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: ANDA078591
TE code: AP
Approval date: Jun 17, 2008
Patents / exclusivity: None on file

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)

Class I · TerminatedFeb 7, 2018
Pfizer Inc. — Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class II · TerminatedJul 26, 2017
HOSPIRA INC, LAKE FOREST — Presence of Particulate Matter: Silicone oil
Class II · TerminatedJul 26, 2017
HOSPIRA INC, LAKE FOREST — Presence of Particulate Matter: Silicone oil
Class II · TerminatedOct 1, 2014
Hospira Inc. — Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.

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 00703-0110-03," retrieved September 3, 2026, https://drugdashboards.com/drug/00703011003.

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