Medicine
Hydromorphone 8 mg extended-release tablet
Hydromorphone 8 mg extended-release tablet 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). Store hydromorphone hydrochloride…
Key facts
- Active ingredient (INN)
- Hydromorphone
- Brand
- Sold under the generic name
- Strength
- 8 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets and 1 more
- Manufacturers
- Camber PharmaceuticalsIndiaPadagisTrigen LaboratoriesXLCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store hydromorphone hydrochloride extended-release 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
- 22 May 2015
- Identifiers
- RxCUI 902729, 902736, 902741 +2DailyMed set ID 90bda45c-9dbe-4ed5-91d0-df8446ad7026, 8bb81796-6990-40e9-bee4-1f292f91ae99, c33e6320-4206-4b69-8cac-ebfc2351b8f2 +1NDC 72865-168, 13811-701, 31722-119 +1Application ANDA212133, ANDA205629, ANDA204278
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 |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 31722-119-01 | Camber PharmaceuticalsIndia | 24 September 2020 |
| 100 tablet, extended release in 1 bottle | 0574-0293-01 | Padagis | 22 May 2015 |
| 100 tablet, extended release in 1 bottle | 13811-701-10 | Trigen Laboratories | 15 September 2016 |
| 100 tablet, extended release in 1 bottle | 72865-168-01 | XLCare Pharmaceuticals | 24 September 2020 |
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
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 8 mg extended-release tablet 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.