Medicine
Acamprosate 333 mg delayed-release tablet
Acamprosate 333 mg delayed-release tablet is a generic prescription medicine for oral use, made by 10 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).
Key facts
- Active ingredient (INN)
- Acamprosate
- Brand
- Sold under the generic name
- Strength
- 333 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 20 more
- Manufacturers
- Zydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaSomerset TherapeuticsAmerican Health PackagingAvPAKBionpharmaMajor PharmaceuticalsMylan PharmaceuticalsRemedyrepackVangard Labs
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07BB03 Acamprosate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2013
- Identifiers
- RxCUI 835726DailyMed set ID 9803db35-2600-4f42-80c1-43216fd1ba3d, 4473326f-79f1-61b2-e063-6294a90a17a3, 75ddfd10-55b2-426e-bc74-3413cd0d7c94 +8NDC 68382-569, 69452-353, 0378-6333 +8Application ANDA205995, ANDA219904, ANDA200142 +2
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, delayed release in 1 bottle | 68382-569-01 | Zydus LifesciencesIndia | 1 June 2017 |
| 500 tablet, delayed release in 1 bottle | 68382-569-05 | Zydus LifesciencesIndia | 1 June 2017 |
| 30 tablet, delayed release in 1 bottle | 68382-569-06 | Zydus LifesciencesIndia | 1 June 2017 |
| 1000 tablet, delayed release in 1 bottle | 68382-569-10 | Zydus LifesciencesIndia | 1 June 2017 |
| 90 tablet, delayed release in 1 bottle | 68382-569-16 | Zydus LifesciencesIndia | 1 June 2017 |
| 180 tablet, delayed release in 1 bottle | 68382-569-28 | Zydus LifesciencesIndia | 1 June 2017 |
| 1000 tablet, delayed release in 1 bottle | 70771-1057-0 | Zydus LifesciencesIndia | 1 June 2017 |
| 100 tablet, delayed release in 1 bottle | 70771-1057-1 | Zydus LifesciencesIndia | 1 June 2017 |
| 30 tablet, delayed release in 1 bottle | 70771-1057-3 | Zydus LifesciencesIndia | 1 June 2017 |
| 500 tablet, delayed release in 1 bottle | 70771-1057-5 | Zydus LifesciencesIndia | 1 June 2017 |
| 180 tablet, delayed release in 1 bottle | 70771-1057-8 | Zydus LifesciencesIndia | 1 June 2017 |
| 90 tablet, delayed release in 1 bottle | 70771-1057-9 | Zydus LifesciencesIndia | 1 June 2017 |
| 10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack | 68462-435-11 | Glenmark PharmaceuticalsIndia | 16 July 2013 |
| 180 tablet, delayed release in 1 bottle | 68462-435-18 | Glenmark PharmaceuticalsIndia | 16 July 2013 |
| 180 tablet, delayed release in 1 bottle | 69452-353-25 | Bionpharma | 1 December 2025 |
| 180 tablet, delayed release in 1 bottle, plastic | 0378-6333-80 | Mylan Pharmaceuticals | 24 September 2014 |
| 180 tablet, delayed release in 1 bottle | 70069-860-18 | Somerset Therapeutics | 10 August 2026 |
| 30 tablet, delayed release in 1 bottle | 70069-860-30 | Somerset Therapeutics | 10 August 2026 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, delayed release in 1 blister pack | 60687-121-25 | American Health Packaging | 27 October 2015 |
| 30 blister pack in 1 box / 1 tablet, delayed release in 1 blister pack | 50268-028-13 | AvPAK | 26 October 2026 |
| 30 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack | 0904-7213-04 | Major Pharmaceuticals | 16 July 2013 |
| 50 pouch in 1 box / 1 tablet, delayed release in 1 pouch | 70518-4616-0 | Remedyrepack | 23 April 2026 |
| 30 tablet, delayed release in 1 blister pack | 0615-8660-39 | Vangard Labs | 15 September 2026 |
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 29 July 2004 | 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
Clinical summary
Acamprosate is a prescription medicine indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It is available as delayed-release tablets for oral use. MedsAcross supplies Acamprosate 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 AcamprosateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ACAMPROSATE CALCIUM prescribing information (Somerset Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Acamprosate 333 mg delayed-release tablet for your hospital or patient?
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