Medicine
Hydromorphone 4 mg tablet
Hydromorphone 4 mg tablet is a generic prescription medicine for oral use, made by 8 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
- 4 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 20 tablets and 39 more
- Manufacturers
- Aurolife PharmaIndiaBryant Ranch PrepackAsclemedRhodes PharmaceuticalsAscent PharmaceuticalsAmerican Health PackagingSpecGx8 labelers on the register
- 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
- 23 December 2004
- Identifiers
- RxCUI 897702, 897696, 897710 +1DailyMed set ID 53ddcacc-99e4-8b21-e063-6394a90a3e79, 18f6f54e-1537-4181-9d07-54ddf881a9ee, 4de15afe-d676-4faa-a34d-9b9cb20dbf54 +6NDC 60760-998, 87063-038, 43602-003 +6Application NDA019892, ANDA210506, ANDA076855 +1
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
A sample of 40 packs from 8 labelers. The register lists 42 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 13107-108-01 | Aurolife PharmaIndia | 17 May 2016 |
| 500 tablet in 1 bottle | 13107-108-05 | Aurolife PharmaIndia | 17 May 2016 |
| 20 tablet in 1 bottle | 13107-108-20 | Aurolife PharmaIndia | 17 May 2016 |
| 1000 tablet in 1 bottle | 13107-108-99 | Aurolife PharmaIndia | 17 May 2016 |
| 500 tablet in 1 bottle | 43602-003-05 | Ascent Pharmaceuticals | 24 January 2018 |
| 30 tablet in 1 bottle | 43602-003-30 | Ascent Pharmaceuticals | 24 January 2018 |
| 100 tablet in 1 bottle, plastic | 42858-302-01 | Rhodes Pharmaceuticals | 23 November 2009 |
| 4 blister pack in 1 carton / 25 tablet in 1 blister pack | 42858-302-25 | Rhodes Pharmaceuticals | 23 November 2009 |
| 500 tablet in 1 bottle, plastic | 42858-302-50 | Rhodes Pharmaceuticals | 23 November 2009 |
| 100 tablet in 1 bottle | 0406-3244-01 | SpecGx | 23 December 2004 |
| 90 tablet in 1 bottle | 71335-0723-0 | Bryant Ranch Prepack | 16 April 2018 |
| 30 tablet in 1 bottle | 71335-0723-1 | Bryant Ranch Prepack | 8 March 2018 |
| 180 tablet in 1 bottle | 71335-0723-2 | Bryant Ranch Prepack | 9 August 2024 |
| 120 tablet in 1 bottle | 71335-0723-3 | Bryant Ranch Prepack | 9 August 2024 |
| 20 tablet in 1 bottle | 71335-0723-4 | Bryant Ranch Prepack | 9 August 2024 |
| 25 tablet in 1 bottle | 71335-0723-5 | Bryant Ranch Prepack | 9 August 2024 |
| 100 tablet in 1 bottle | 71335-0723-6 | Bryant Ranch Prepack | 9 August 2024 |
| 60 tablet in 1 bottle | 71335-0723-7 | Bryant Ranch Prepack | 16 April 2018 |
| 56 tablet in 1 bottle | 71335-0723-8 | Bryant Ranch Prepack | 9 August 2024 |
| 140 tablet in 1 bottle | 71335-0723-9 | Bryant Ranch Prepack | 9 August 2024 |
| 90 tablet in 1 bottle, plastic | 71335-9701-0 | Bryant Ranch Prepack | 26 February 2025 |
| 30 tablet in 1 bottle, plastic | 71335-9701-1 | Bryant Ranch Prepack | 12 January 2026 |
| 180 tablet in 1 bottle, plastic | 71335-9701-2 | Bryant Ranch Prepack | 10 April 2026 |
| 120 tablet in 1 bottle, plastic | 71335-9701-3 | Bryant Ranch Prepack | 10 April 2026 |
| 20 tablet in 1 bottle, plastic | 71335-9701-4 | Bryant Ranch Prepack | 10 April 2026 |
| 25 tablet in 1 bottle, plastic | 71335-9701-5 | Bryant Ranch Prepack | 10 April 2026 |
| 100 tablet in 1 bottle, plastic | 71335-9701-6 | Bryant Ranch Prepack | 10 April 2026 |
| 60 tablet in 1 bottle, plastic | 71335-9701-7 | Bryant Ranch Prepack | 30 July 2024 |
| 56 tablet in 1 bottle, plastic | 71335-9701-8 | Bryant Ranch Prepack | 10 April 2026 |
| 140 tablet in 1 bottle, plastic | 71335-9701-9 | Bryant Ranch Prepack | 10 April 2026 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 60687-590-01 | American Health Packaging | 11 May 2021 |
| 100 tablet in 1 bottle, plastic | 87063-038-01 | Asclemed | 4 December 2025 |
| 5 tablet in 1 bottle, plastic | 87063-038-05 | Asclemed | 4 December 2025 |
| 7 tablet in 1 bottle, plastic | 87063-038-07 | Asclemed | 4 December 2025 |
| 10 tablet in 1 bottle, plastic | 87063-038-10 | Asclemed | 4 December 2025 |
| 14 tablet in 1 bottle, plastic | 87063-038-14 | Asclemed | 4 December 2025 |
| 20 tablet in 1 bottle, plastic | 87063-038-20 | Asclemed | 4 December 2025 |
| 30 tablet in 1 bottle, plastic | 87063-038-30 | Asclemed | 4 December 2025 |
| 500 tablet in 1 bottle, plastic | 87063-038-50 | Asclemed | 3 December 2025 |
| 60 tablet in 1 bottle, plastic | 87063-038-60 | Asclemed | 4 December 2025 |
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 4 mg tablet.
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 4 mg 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.