Active substance
Hydromorphone
- SFDA 5
- US FDA 32
- Health Canada 35
- US price lines 13
- NHS prices 6
- WHO EML 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| JURNISTA 16 mg prolonged-release tablet | 16 mg | Prolonged-release tablet · Oral use | 28 Blister | SAR 245.40 | NCE · Prescription | JANSSEN-CILAG | Valid |
| JURNISTA 32 mg prolonged-release tablet | 32 mg | Prolonged-release tablet · Oral use | 28 Blister | SAR 453.00 | NCE · Prescription | JANSSEN-CILAG | Valid |
| JURNISTA 8 mg prolonged-release tablet | 8 mg | Prolonged-release tablet · Oral use | 28 Blister | SAR 155.30 | NCE · Prescription | JANSSEN-CILAG | Valid |
| Potamerf | 2 mg/ml | Solution for injection/infusion · Intravenous, Intramuscular, Subcutaneous | 10 Vial | SAR 134.20 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| JURNISTA 64 mg prolonged-release tablet | 64 mg | Prolonged-release tablet · Oral use | 28 Blister | SAR 798.40 | NCE · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE PANCREATITIS-PAIN MANAGEMENT; ANESTHESIA; CHRONIC PANCREATITIS; DIABETIC NEUROPATHY; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; LOW BACK PAIN; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; SICKLE CELL DISEASE - PAIN MANAGEMENT
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DILAUDID-HP | 10MG/ML | injectable · injection | FRESENIUS KABI USA | Prescription | 11 Jan 1984 |
| DILAUDID | 1MG/ML; 2MG/ML; 4MG/ML; 0.2MG/ML; 0.5MG/0.5ML | injectable · injection | FRESENIUS KABI USA | Prescription | 11 Jan 1984 |
| DILAUDID | 5MG/5ML | solution · oral | RHODES PHARMS | Prescription | 7 Dec 1992 |
| DILAUDID | 8MG; 4MG; 2MG | tablet · oral | RHODES PHARMS | Prescription | 7 Dec 1992 |
| HYDROMORPHONE HYDROCHLORIDE | 5MG/5ML | solution · oral | HIKMA PHARMS | Prescription | 29 Jul 1998 |
| HYDROMORPHONE HYDROCHLORIDE | 8MG; 2MG; 4MG | tablet · oral | SPECGX LLC | Prescription | 23 Dec 2004 |
| HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | injectable · injection | HOSPIRA INC | Prescription | 17 Jun 2008 |
| HYDROMORPHONE HYDROCHLORIDE | 2MG; 4MG | tablet · oral | LANNETT | Prescription | 9 Dec 2009 |
| HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | injectable · injection | RISING | Prescription | 14 Apr 2010 |
| HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | injectable · injection | RISING | Prescription | 14 Apr 2010 |
| HYDROMORPHONE HYDROCHLORIDE | 1MG/ML; 2MG/ML; 4MG/ML; 0.5MG/0.5ML; 0.25MG/0.5ML | injectable · injection | HOSPIRA INC | Prescription | 1 Dec 2011 |
| HYDROMORPHONE HYDROCHLORIDE | 8MG; 12MG; 16MG; 32MG | tablet, extended release · oral | PADAGIS US | Prescription | 6 Apr 2015 |
| HYDROMORPHONE HYDROCHLORIDE | 2MG; 4MG; 8MG | tablet · oral | AUROLIFE PHARMA LLC | Prescription | 13 May 2016 |
| HYDROMORPHONE HYDROCHLORIDE | 8MG; 12MG; 16MG; 32MG; 24MG | tablet, extended release · oral | OSMOTICA PHARM US | Prescription | 7 Jul 2016 |
| HYDROMORPHONE HYDROCHLORIDE | 5MG/5ML | solution · oral | ASCENT PHARMS INC | Prescription | 27 Oct 2017 |
| HYDROMORPHONE HYDROCHLORIDE | 2MG; 4MG; 8MG | tablet · oral | ASCENT PHARMS INC | Prescription | 17 Jan 2018 |
| HYDROMORPHONE HYDROCHLORIDE | 2MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 27 Apr 2018 |
| HYDROMORPHONE HYDROCHLORIDE | 8MG; 12MG; 16MG; 32MG | tablet, extended release · oral | ASCENT PHARMS INC | Prescription | 23 Sep 2020 |
| HYDROMORPHONE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | solution · intramuscular, intravenous, subcutaneous | HIKMA | Prescription | 14 Dec 2023 |
| HYDROMORPHONE HYDROCHLORIDE | 0.2MG/ML; 0.5MG/0.5ML; 1MG/ML; 2MG/ML | injectable · injection | HIKMA | Prescription | 9 Feb 2024 |
| DILAUDID-HP | 250MG/VIAL | injectable · injection | FRESENIUS KABI USA | Discontinued | 11 Jan 1984 |
| HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | injectable · injection | WATSON LABS | Discontinued | 23 Aug 1995 |
| HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | injectable · injection | HOSPIRA | Discontinued | 19 Jun 1997 |
| HYDROMORPHONE HYDROCHLORIDE | 8MG; 4MG | tablet · oral | HIKMA PHARMS | Discontinued | 29 Jul 1998 |
| HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | injectable · injection | BARR | Discontinued | 25 Apr 2003 |
7 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-HYDROMORPHONE | 02364115 | 1 MG | TABLET · ORAL | APOTEX INC |
| APO-HYDROMORPHONE | 02364123 | 2 MG | TABLET · ORAL | APOTEX INC |
| APO-HYDROMORPHONE | 02364131 | 4 MG | TABLET · ORAL | APOTEX INC |
| APO-HYDROMORPHONE | 02364158 | 8 MG | TABLET · ORAL | APOTEX INC |
| DILAUDID | 00125083 | 2 MG | TABLET · ORAL | PURDUE PHARMA |
| DILAUDID | 00125121 | 4 MG | TABLET · ORAL | PURDUE PHARMA |
| DILAUDID | 00705438 | 1 MG | TABLET · ORAL | PURDUE PHARMA |
| DILAUDID | 00786543 | 8 MG | TABLET · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN | 02359502 | 4.5 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN | 02359510 | 9 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 12MG | 02125366 | 12 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 18MG | 02243562 | 18 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 24MG | 02125382 | 24 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 30MG | 02125390 | 30 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 3MG | 02125323 | 3 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 6MG | 02125331 | 6 MG | CAPSULE (SUSTAINED-RELEASE) · ORAL | PURDUE PHARMA |
| HYDROMORPHONE HP 10 | 02145928 | 10 MG / ML | SOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| HYDROMORPHONE HP 20 | 02145936 | 20 MG / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| HYDROMORPHONE HP 50 | 02146126 | 50 MG / ML | SOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| HYDROMORPHONE HYDROCHLORIDE INJECTION | 02460602 | 2 MG / ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR | STERIMAX INC |
| HYDROMORPHONE HYDROCHLORIDE INJECTION HP 10 | 02460610 | 10 MG / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS | STERIMAX INC |
| HYDROMORPHONE HYDROCHLORIDE INJECTION HP 50 | 02469413 | 50 MG / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS | STERIMAX INC |
| HYDROMORPHONE HYDROCHLORIDE INJECTION HP FORTE | 02468468 | 100 MG / ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR | STERIMAX INC |
| HYDROMORPHONE HYDROCHLORIDE INJECTION USP | 02145901 | 2 MG / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
| HYDROMORPHONE HYDROCHLORIDE INJECTION USP | 02485532 | 20 MG / 50 ML | SOLUTION · INTRAVENOUS | STERINOVA INC. |
10 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | HYDROMORPHONE 1 MG/ML SOLUTION | $0.23587 | per ML | 23 Sep 2026 |
| US NADAC | HYDROMORPHONE 10 MG/ML VIAL | $2.56628 | per ML | 20 May 2026 |
| US NADAC | HYDROMORPHONE 2 MG TABLET | $0.16941 | per EA | 23 Sep 2026 |
| US NADAC | HYDROMORPHONE 2 MG/ML VIAL | $2.74032 | per ML | 22 Jul 2026 |
| US NADAC | HYDROMORPHONE 4 MG TABLET | $0.21916 | per EA | 23 Sep 2026 |
| US NADAC | HYDROMORPHONE 5 MG/5 ML SOLN | $0.23587 | per ML | 23 Sep 2026 |
| US NADAC | HYDROMORPHONE 50 MG/5 ML VIAL | $2.56628 | per ML | 20 May 2026 |
| US NADAC | HYDROMORPHONE 500 MG/50 ML VIAL | $2.56628 | per ML | 20 May 2026 |
| US NADAC | HYDROMORPHONE 500 MG/50 ML VL | $2.56628 | per ML | 20 May 2026 |
| US NADAC | HYDROMORPHONE 8 MG TABLET | $0.56093 | per EA | 23 Sep 2026 |
| US NADAC | HYDROMORPHONE HCL ER 12 MG TAB | $10.42125 | per EA | 23 Sep 2026 |
| US NADAC | HYDROMORPHONE HCL ER 16 MG TAB | $12.38018 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Hydromorphone 1.3mg capsules | £8.82 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Hydromorphone 10mg/1ml solution for injection ampoules | £66.00 | 5 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Hydromorphone 2mg modified-release capsules | £20.98 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Hydromorphone 2mg/1ml solution for injection ampoules | £7.99 | 5 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Hydromorphone 4mg modified-release capsules | £28.75 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Hydromorphone 8mg modified-release capsules | £56.08 | 56 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 2.2. Opioid analgesics · core
Therapeutic equivalent to morphine for Pain
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 DILAUDID — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 DILAUDID — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 DILAUDID-HP — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 HYDROMORPHONE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 HYDROMORPHONE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations - US FDA 7 Oct 2019 EXALGO — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.