Hydromorphone
Hydromorphone is a strong opioid pain reliever used to manage severe pain when other treatments are not adequate, available as oral tablets, oral solution, extended-release tablets, injectable solution, and rectal suppositories.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 20 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Hydromorphone carries serious, life-threatening risks that every patient and caregiver should know.
- Dosing errors can be deadly: The oral solution can be confused between milligrams (mg) and milliliters (mL), or mixed up with other concentrations. Always use a proper measuring device — never a kitchen spoon.
- Addiction, abuse, and misuse: Even when used as prescribed, hydromorphone can lead to addiction or be misused, which can result in overdose and death.
- Breathing can slow or stop: Dangerous or fatal respiratory depression (slowed or stopped breathing) can happen, especially when starting the medicine or after a dose increase. If someone is hard to wake up, breathing very slowly, or not breathing — call 911 immediately.
- Accidental ingestion by children can be fatal: Even one dose can kill a child. Store securely and out of reach.
- Combining with other sedating drugs or alcohol is extremely dangerous: Using hydromorphone together with benzodiazepines, alcohol, or other central nervous system depressants can cause profound sedation, stopped breathing, coma, and death.
- Use during pregnancy: Long-term use during pregnancy can cause a serious withdrawal condition in the newborn (neonatal opioid withdrawal syndrome), which can be life-threatening if not quickly recognized and treated.
📖 Hydromorphone: Patient Information Guide
A plain-language walkthrough of Hydromorphone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Hydromorphone is an opioid pain reliever indicated for severe pain when other treatments are not adequate, across several formulations:
- Oral tablets and oral solution — for pain severe enough to require an opioid, when alternatives have not worked or are not expected to work
- Extended-release (ER) tablets — for severe, persistent pain needing around-the-clock opioid treatment for an extended time; for opioid-tolerant patients only; not for as-needed use
- Injectable solution (intramuscular, intravenous, subcutaneous) — for severe pain requiring an opioid when alternatives are inadequate
- High-potency injectable formulation (HPF) — specifically for opioid-tolerant patients who require higher opioid doses; patients must continue around-the-clock opioids while using this formulation
- Rectal suppositories — for severe pain when an opioid is required and alternatives are inadequate
- All formulations are reserved for patients for whom non-opioid analgesics or combination opioid products are not effective, not tolerated, or expected to be insufficient
⚙️How it works▾
Hydromorphone is a semi-synthetic opioid derived from morphine. It works as a full opioid agonist — it binds to and activates mu-opioid receptors in the brain and spinal cord, which are the same receptors involved in the body's natural pain control system. This activation reduces how intensely the brain processes pain signals. Unlike some other pain medicines, there is no built-in ceiling on how much pain relief it can provide — but higher doses also raise the risk of serious side effects, especially dangerously slow or stopped breathing.
As doses rise, the relationship between drug levels in the blood and side effects like nausea, sedation, and respiratory depression becomes more pronounced. In patients who have taken opioids long-term, tolerance to some side effects can develop over time.
💊How it's taken▾
How and how often you take hydromorphone depends entirely on which form is prescribed — always follow your prescriber's instructions exactly.
- Oral tablets and oral solution: Taken by mouth; frequency is individualized. The oral solution must be measured with an accurate graduated device — never a household teaspoon or tablespoon.
- Extended-release tablets: Taken once daily by mouth, with or without food. Swallow whole — do not crush, chew, or dissolve. For opioid-tolerant patients only.
- Rectal suppositories: Typically every 6 to 8 hours for adults, as directed.
- Injections: Given by a healthcare professional in a clinical setting.
Never stop taking hydromorphone suddenly if you have been on it regularly — abrupt discontinuation can cause serious withdrawal symptoms. Talk to your prescriber about how to taper safely if it needs to be stopped.
🤒Side effects — in detail▾
The most commonly reported side effects with hydromorphone include:
- Constipation
- Nausea and vomiting
- Drowsiness (somnolence)
- Headache
- Dizziness
- Fatigue or weakness
- Itching (pruritus)
- Dry mouth and excessive sweating
Get emergency help immediately for any signs of slowed or stopped breathing, extreme sedation you cannot be roused from, or chest pain. Contact your doctor promptly for signs of adrenal insufficiency (persistent nausea, severe tiredness), unusual pain sensitivity, mood changes, or difficulty urinating.
⚠️Warnings & precautions▾
- Respiratory depression (dangerously slowed breathing): The most serious risk. Can occur at any time, but is greatest when starting therapy or increasing the dose. Fatal in some cases. Call 911 immediately if someone is breathing very slowly or cannot be woken.
- Addiction, abuse, and misuse: Hydromorphone is a Schedule II controlled substance. Addiction can occur even at prescribed doses. Patients with a personal or family history of substance use disorder or mental illness are at higher risk.
- Accidental ingestion by children: Even one dose can be fatal. Store securely.
- Combining with CNS depressants or alcohol: Extremely dangerous — can result in coma or death. This includes benzodiazepines, sleep aids, antipsychotics, gabapentinoids, other opioids, and alcohol.
- Neonatal opioid withdrawal syndrome: Prolonged use during pregnancy can cause serious withdrawal in the newborn.
- Opioid-induced hyperalgesia: In some cases, the medication can paradoxically increase pain sensitivity over time.
- Severe hypotension (very low blood pressure): Can occur, especially in patients with circulatory problems.
- Head injury or increased intracranial pressure: Use with caution; hydromorphone can worsen these conditions.
🔀What it interacts with▾
Hydromorphone has several important drug and substance interactions that can be dangerous or even life-threatening:
- Benzodiazepines and sedatives/sleep aids — dramatically increase risk of fatal respiratory depression and coma; avoid combining unless absolutely necessary and under close medical supervision
- Alcohol — adds to sedation and breathing suppression; avoid entirely
- Other opioids — additive sedation and respiratory depression
- MAO inhibitors (MAOIs) — can cause severe toxicity including respiratory depression and serotonin syndrome; do not use within 14 days of stopping an MAOI
- Antidepressants (SSRIs, SNRIs, TCAs) and other serotonergic drugs — risk of serotonin syndrome (agitation, fever, rapid heart rate, muscle twitching)
- Gabapentin or pregabalin — increased sedation and breathing risk when combined
- Muscle relaxants — may worsen respiratory depression
- Anticholinergic drugs — increases risk of constipation severe enough to cause bowel obstruction, and urinary retention
- Diuretics (water pills) — opioids can reduce their effectiveness; monitor for fluid changes
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- You are not opioid-tolerant — extended-release tablets and the high-potency injectable are contraindicated in opioid-naive patients due to risk of fatal respiratory depression
- You have significant respiratory depression or severe uncontrolled asthma, especially in an unmonitored setting
- You have a known or suspected bowel blockage (paralytic ileus) or narrowed gastrointestinal tract — contraindicated for extended-release tablets
- You have a known allergy or severe hypersensitivity reaction (anaphylaxis) to hydromorphone
- You are pregnant — long-term use can cause neonatal opioid withdrawal syndrome in the newborn; not recommended near the time of delivery
- You are breastfeeding — hydromorphone passes into breast milk; breastfeeding is not recommended during treatment
- You are elderly (65+) — more sensitive to side effects, especially breathing problems; dose adjustments are typically needed
- You have moderate or severe liver disease — drug levels can increase significantly; severe hepatic impairment warrants using an alternative analgesic
- You have moderate or severe kidney disease — drug levels may increase; consider an alternate analgesic for severe impairment
- You have a personal or family history of substance use disorder or mental health conditions — higher risk of addiction; requires careful monitoring
🚑If you take too much▾
An overdose of hydromorphone can cause extremely slow or stopped breathing, deep sedation progressing to unconsciousness or coma, limpness of the muscles, pinpoint pupils, cold and clammy skin, and dangerously low blood pressure — and can be fatal. If you suspect an overdose, call 911 immediately and, if available, administer an opioid overdose reversal agent such as naloxone.
For extended-release tablets specifically, the drug continues to be released from the tablet for up to 24 to 48 hours after ingestion, so medical monitoring must continue even after initial treatment with a reversal agent, since the reversal agent wears off faster than the drug itself.
📡Pharmacodynamics — effects in the body▾
Hydromorphone directly depresses the brain's respiratory centers in a dose-dependent way, reducing the body's response to rising carbon dioxide levels — which is why breathing slows. It also causes the pupils to constrict (become very small, or "pinpoint"), slows movement through the stomach and intestines (leading to constipation), and can cause blood vessels to widen, sometimes resulting in a drop in blood pressure when you stand up (orthostatic hypotension). With longer-term use, it can interfere with hormone pathways, potentially reducing sex hormone levels and affecting fertility, libido, and menstrual cycles.
🔬Pharmacokinetics — how your body processes it▾
When taken as extended-release tablets, hydromorphone is absorbed gradually, with blood levels rising over 6 to 8 hours and remaining stable for up to 18 to 24 hours; the average half-life is about 11 hours. It is processed primarily in the liver and approximately 75% of a dose leaves the body through the urine, mostly as metabolites. Patients with moderate liver disease can have blood levels four times higher than normal, and moderate-to-severe kidney disease also raises drug exposure significantly — making dose adjustments or alternative medications necessary in those groups. Food does not meaningfully affect the absorption of the extended-release tablet formulation.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F) . Protect from light. Store hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets securely and dispose of properly.
📄 Written from Hydromorphone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Hydromorphone
100 supplements and herbal products have documented interactions with Hydromorphone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 78
- Minor · 15
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Hydromorphone — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is hydromorphone and why did my doctor prescribe it instead of something else? ▾
Is it safe to take a sleep aid, anxiety pill, or have a glass of wine while on this? ▾
What side effects should I expect, and which ones should make me call for help right away? ▾
I've heard opioids are addictive — should I be worried about that with hydromorphone? ▾
If I'm pregnant or thinking about getting pregnant, is this safe to take? ▾
Can I stop taking hydromorphone whenever I want if I feel better? ▾
Is Hydromorphone available over the counter? ▾
Is Hydromorphone a controlled substance? ▾
When was Hydromorphone first available? ▾
Who makes Hydromorphone? ▾
💬 Answers drafted from Hydromorphone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Hydromorphone comes
Hydromorphone is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
Tablet
Extended-release tablet
Oral solution
Rectal suppository
📊 Hydromorphone across the U.S. market
How Hydromorphone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Hydromorphone is used
A general measure of how commonly Hydromorphone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Hydromorphone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Hydromorphone prescribed? Of the 1,596 medications we measure, Hydromorphone ranks #296 by Medicaid prescriptions — more than 81% of them.
Utilization by Hydromorphone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
hydromorphone hydrochloride 2 MG Oral Tablet Most dispensed
Summed across the 4 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897696
1 ML hydromorphone hydrochloride 1 MG/ML Cartridge
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724383
0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe
Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433251
hydromorphone hydrochloride 4 MG Oral Tablet
Summed across the 5 of 76 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897702
1 ML hydromorphone hydrochloride 2 MG/ML Injection
Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724276
1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe
Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897756
hydromorphone hydrochloride 8 MG Oral Tablet
Summed across the 2 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897710
1 ML hydromorphone hydrochloride 1 MG/ML Injection
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897653
1 ML hydromorphone hydrochloride 2 MG/ML Cartridge
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724644
hydromorphone hydrochloride 1 MG/ML Oral Solution
Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897657
1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe
Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897757
1 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled Syringe
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2277368
50 ML hydromorphone hydrochloride 10 MG/ML Injection
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724341
24 HR hydromorphone hydrochloride 8 MG Extended Release Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 902741
5 ML hydromorphone hydrochloride 10 MG/ML Injection
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724340
0.5 ML hydromorphone hydrochloride 0.5 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2675350
hydromorphone hydrochloride 2 MG/ML Injectable Solution
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897745
24 HR hydromorphone hydrochloride 12 MG Extended Release Oral Tablet
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 902729
1 ML hydromorphone hydrochloride 10 MG/ML Injection
Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724338
24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 902736
1 ML hydromorphone hydrochloride 4 MG/ML Cartridge
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897758
hydromorphone hydrochloride 3 MG Rectal Suppository
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897749
1 ML hydromorphone hydrochloride 4 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897753
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hydromorphone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 45 of 259 listed Hydromorphone NDCs with Medicaid activity.
🔍 Compare Hydromorphone products
A representative set of FDA-listed product records for Hydromorphone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 8 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 12 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 16 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 32 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 8 mg | Oral | Camber Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 12 mg | Oral | Camber Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 16 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 32 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 💊Injection | ||||
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Akorn | ANDA | View NDC → |
| 100 mg/mL | — | Bond Pharmacy INC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 0.2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC × 2 listings | NDA | View NDC → |
| 0.2 mg/mL | Intramuscular; Intravenous; Subcutaneous | Fresenius Kabi USA, LLC × 2 listings | NDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC × 4 listings | NDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | Fresenius Kabi USA, LLC × 4 listings | NDA | View NDC → |
| 2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC × 4 listings | NDA | View NDC → |
| 2 mg/mL | Intramuscular; Intravenous; Subcutaneous | Fresenius Kabi USA, LLC × 4 listings | NDA | View NDC → |
| 4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC × 2 listings | NDA | View NDC → |
| 4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Fresenius Kabi USA, LLC | NDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC × 2 listings | NDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Fresenius Kabi USA, LLC | NDA | View NDC → |
| 0.2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 0.5 mg/0.5 mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. × 4 listings | ANDA | View NDC → |
| 2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | UNAPPROVED DRUG OTHER | View NDC → |
| 2 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hikma Pharmaceuticals USA Inc. × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 2 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. × 2 listings | NDA | View NDC → |
| 0.25 mg/0.5 mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. | NDA | View NDC → |
| 0.5 mg/0.5 mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. | NDA | View NDC → |
| 0.5 mg/0.5 mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 2 listings | NDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. × 2 listings | NDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 6 listings | NDA | View NDC → |
| 2 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. × 3 listings | NDA | View NDC → |
| 2 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 6 listings | NDA | View NDC → |
| 4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. | NDA | View NDC → |
| 4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 2 listings | NDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intramuscular, Intravenous, Subcutaneous | Teva Parenteral Medicines, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intramuscular; Intravenous; Subcutaneous | Teva Parenteral Medicines, Inc. × 3 listings | ANDA | View NDC → |
| 💊Oral solution | ||||
| 5 mg/5 mL | Oral | American Health Packaging × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg/5 mL | Oral | Ascent Pharmaceuticals Inc | ANDA | View NDC → |
| 1 mg/mL | Oral | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 1 mg/mL | Oral | Hikma Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 1 mg/mL | Oral | Lohxa | ANDA | Find on DailyMed ↗ |
| 5 mg/5 mL | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg/5 mL | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA | View NDC → |
| 5 mg/5 mL | Oral | Rhodes Pharmaceuticals LLC | NDA | View NDC → |
| 5 mg/5 mL | Oral | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 💊Rectal suppository | ||||
| 3 mg | Rectal | Bryant Ranch Prepack × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 3 mg | Rectal | Padagis US LLC × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 💊Tablet | ||||
| 2 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 4 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 2 mg | Oral | Ascent Pharmaceuticals Inc | ANDA | View NDC → |
| 4 mg | Oral | Ascent Pharmaceuticals Inc | ANDA | View NDC → |
| 8 mg | Oral | Ascent Pharmaceuticals Inc | ANDA | View NDC → |
| 2 mg | Oral | Asclemed Usa Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 4 mg | Oral | Asclemed Usa Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 8 mg | Oral | Asclemed Usa Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 2 mg | Oral | Aurolife Pharma, LLC × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Aurolife Pharma, LLC × 2 listings | ANDA | View NDC → |
| 8 mg | Oral | Aurolife Pharma, LLC × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack × 5 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 4 mg | Oral | Bryant Ranch Prepack × 4 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 8 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 8 mg | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 4 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 8 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Redpharm Drug | ANDA | View NDC → |
| 2 mg | Oral | RedPharm Drug, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA | View NDC → |
| 2 mg | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 4 mg | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA | View NDC → |
| 4 mg | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 8 mg | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 8 mg | Oral | Rhodes Pharmaceuticals L.P. × 2 listings | NDA | View NDC → |
| 2 mg | Oral | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 2 mg | Oral | Rhodes Pharmaceuticals LLC | NDA | View NDC → |
| 4 mg | Oral | Rhodes Pharmaceuticals LLC | NDA | View NDC → |
| 4 mg | Oral | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 8 mg | Oral | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 8 mg | Oral | Rhodes Pharmaceuticals LLC | NDA | View NDC → |
| 2 mg | Oral | SpecGx LLC × 4 listings | ANDA | View NDC → |
| 4 mg | Oral | SpecGx LLC × 4 listings | ANDA | View NDC → |
| 8 mg | Oral | SpecGx LLC × 4 listings | ANDA | View NDC → |
| 4 mg | Oral | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Cambrex Charles City, Inc | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Chattem Chemicals, Inc. | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Fagron Inc | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Janssen Pharmaceutical Sciences Unlimited | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Letco Medical, Llc | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 g/g | — | Medisca Inc. | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Noramco, LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Pharma Source Direct, Inc. | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Professional Compounding Centers of America | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America × 2 listings | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Purisys LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Siegfried USA, LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | SpecGx LLC | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Veranova, L.P. × 3 listings | BULK INGREDIENT | View NDC → |
Showing 200 of 240 products — FDA National Drug Code Directory. See every product, package size and price: browse all 240 Hydromorphone NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Hydromorphone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Hydromorphone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Hydromorphone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3423 10 dose forms · 32 strengths
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Dose form (SCDF) Cartridge RxCUI 1724190No current FDA listingClinical drug / strength (SCD) 1 ML hydromorphone hydrochloride 1 MG/MLRxCUI 17243831 ML hydromorphone hydrochloride 2 MG/MLRxCUI 17246441 ML hydromorphone hydrochloride 4 MG/MLRxCUI 897758 -
Dose form (SCDF) Extended Release Oral Capsule RxCUI 372427No current FDA listingClinical drug / strength (SCD) 12 HR hydromorphone hydrochloride 2 MGRxCUI 89861112 HR hydromorphone hydrochloride 4 MGRxCUI 89861412 HR hydromorphone hydrochloride 8 MGRxCUI 898618 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 902728In current FDA listingsClinical drug / strength (SCD) 24 HR hydromorphone hydrochloride 12 MGRxCUI 90272924 HR hydromorphone hydrochloride 16 MGRxCUI 90273624 HR hydromorphone hydrochloride 32 MGRxCUI 130689824 HR hydromorphone hydrochloride 8 MGRxCUI 902741 -
Dose form (SCDF) Injectable Solution RxCUI 370652In current FDA listingsClinical drug / strength (SCD) hydrochloride 2 MG/MLRxCUI 897745 -
Dose form (SCDF) Injection RxCUI 1724207In current FDA listingsClinical drug / strength (SCD) 1 ML hydromorphone hydrochloride 1 MG/MLRxCUI 8976531 ML hydromorphone hydrochloride 10 MG/MLRxCUI 17243381 ML hydromorphone hydrochloride 2 MG/MLRxCUI 17242761 ML hydromorphone hydrochloride 4 MG/MLRxCUI 8977535 ML hydromorphone hydrochloride 10 MG/MLRxCUI 172434050 ML hydromorphone hydrochloride 10 MG/MLRxCUI 1724341 -
Dose form (SCDF) Oral Capsule RxCUI 385569No current FDA listingClinical drug / strength (SCD) hydrochloride 1.3 MGRxCUI 898004hydrochloride 2.6 MGRxCUI 898138 -
Dose form (SCDF) Oral Solution RxCUI 370653In current FDA listingsClinical drug / strength (SCD) hydrochloride 1 MG/MLRxCUI 897657 -
Dose form (SCDF) Oral Tablet RxCUI 370654In current FDA listingsClinical drug / strength (SCD) hydrochloride 1 MGRxCUI 897771hydrochloride 2 MGRxCUI 897696hydrochloride 3 MGRxCUI 898139hydrochloride 4 MGRxCUI 897702hydrochloride 8 MGRxCUI 897710 -
Dose form (SCDF) Prefilled Syringe RxCUI 763042No current FDA listingClinical drug / strength (SCD) 0.5 ML hydromorphone hydrochloride 0.5 MG/MLRxCUI 26753500.5 ML hydromorphone hydrochloride 1 MG/MLRxCUI 14332511 ML hydromorphone hydrochloride 0.2 MG/MLRxCUI 22773681 ML hydromorphone hydrochloride 1 MG/MLRxCUI 8977561 ML hydromorphone hydrochloride 2 MG/MLRxCUI 8977571 ML hydromorphone hydrochloride 4 MG/MLRxCUI 1872271 -
Dose form (SCDF) Rectal Suppository RxCUI 370655In current FDA listingsClinical drug / strength (SCD) hydrochloride 3 MGRxCUI 897749
Look up RxCUI 3423 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Hydromorphone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
…and 14 more on the FDA NDC directory.
RxNorm drug class
Hydromorphone belongs to the Opioid Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 20 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Rhodes Pharmaceuticals L.P. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.