Medicine
Morphine 80 mg extended-release capsule
Morphine 80 mg extended-release capsule is a generic prescription medicine for oral use, made by 3 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°C to 25°C (68°F to 77°F). Protect from light and moisture. Store…
Key facts
- Active ingredient (INN)
- Morphine
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 30 capsules and 3 more
- Manufacturers
- Amneal Pharmaceuticals of New YorkUpsher-Smith LaboratoriesNortec Development Associates
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from light and moisture. Store Morphine Sulfate Extended-Release Capsules securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N02AA01 Morphine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 April 2009
- Identifiers
- RxCUI 892345, 892352, 892554 +5DailyMed set ID 9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4, 97948a8f-7d1b-4614-b11d-e944cf56590b, f7e9a4b3-a2ee-4f0a-becd-6ef90867332bNDC 42689-009, 0832-0230, 0115-1281Application ANDA203158, ANDA202104, ANDA200411
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 capsule, extended release in 1 bottle | 0115-1281-01 | Amneal Pharmaceuticals of New York | 12 April 2016 |
| 1000 capsule, extended release in 1 bottle | 0115-1281-03 | Amneal Pharmaceuticals of New York | 12 April 2016 |
| 30 capsule, extended release in 1 bottle | 0115-1281-08 | Amneal Pharmaceuticals of New York | 12 April 2016 |
| 100 capsule, extended release in 1 bottle | 42689-009-01 | Nortec Development Associates | 7 April 2009 |
| 100 capsule, extended release in 1 bottle | 0832-0230-00 | Upsher-Smith Laboratories | 30 June 2013 |
| 500 capsule, extended release in 1 bottle | 0832-0230-50 | Upsher-Smith Laboratories | 30 June 2013 |
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 18 September 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 Morphine
Clinical summary
Morphine is an opioid agonist indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. MedsAcross supplies Morphine 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 MorphineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- INFUMORPH 200 prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Morphine 80 mg extended-release capsule 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.