Medicine
Hydromorphone 5 mg/5 mL oral solution
Hydromorphone 5 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F). Protect from light. Store hydromorphone…
Key facts
- Active ingredient (INN)
- Hydromorphone
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 3 trays and 1 more
- Manufacturers
- American Health PackagingAscent PharmaceuticalsHikma PharmaceuticalsRhodes Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- 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.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N02AA03 Hydromorphone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2012
- Identifiers
- RxCUI 897657, 897696, 897702 +1DailyMed set ID fab97112-e276-40e0-bc82-0a29d7fa75fa, e8fd7b0e-22b9-4f8a-8eb2-41d5031779af, 37565441-0d95-4743-a695-d7b3326f58a1 +1NDC 60687-566, 43602-001, 42858-304 +1Application NDA019891, ANDA210176, ANDA074653
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 473 mL in 1 bottle | 43602-001-47 | Ascent Pharmaceuticals | 4 May 2019 |
| 473 mL in 1 bottle | 0054-0386-63 | Hikma Pharmaceuticals | 1 March 2012 |
| 473 mL in 1 bottle, plastic | 42858-304-16 | Rhodes Pharmaceuticals | 20 July 2012 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-566-86 | American Health Packaging | 30 September 2021 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 11 January 1984 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Hydromorphone 5 mg/5 mL oral solution.
Other strengths and forms of Hydromorphone
Clinical summary
Hydromorphone is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. MedsAcross supplies Hydromorphone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about HydromorphoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dilaudid prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Hydromorphone 5 mg/5 mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.