Prescription medicine
Acamprosate First approved as Campral
Acamprosate (Campral) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.589 per acamprosate calc DR 333 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the acamprosate FDA label on DailyMed (effective July 14, 2026, Somerset Therapeutics, LLC); the NDA 21431 record on Drugs@FDA; every acamprosate label on DailyMed.
Highlights of the record
FDA label of July 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAcamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
Forms and strengths
- 333 mg
Delayed-release tablet.
On the market
- Earliest approval on file
- July 29, 2004 Campral, Forest Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first July 16, 2013; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.589 per tablet Acamprosate calc DR 333 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest July 24, 2026
- FAERS reports
- 322 through July 30, 2026
What is acamprosate used for?
From the label: indications and usageAcamprosate calcium is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium treatment. The efficacy of acamprosate calcium in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. […]
Conditions named in the indications of acamprosate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (ACAMPROSATE CALCIUM), Somerset Therapeutics, LLC, effective July 14, 2026 (SPL set 1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5), via openFDA; the full label on DailyMed
Is there a generic for acamprosate (Campral)?
The FDA approved the first generic acamprosate on July 16, 2013. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acamprosate from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acamprosate (Campral)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.589 per Acamprosate calc DR 333 mg tablet, down 1% from $0.596 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Acamprosate calc DR 333 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acamprosate calc DR 333 mg tablet | Generic | $0.589 per tablet | $17.67 | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acamprosate been recalled?
The FDA's Enforcement Report lists 1 recall naming acamprosate since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2026 | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acamprosate label say about other medicines?
The acamprosate label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Diazepam | drug interactions | The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [ see Clinical Pharmacology ( 12.3 ) ]. |
| Disulfiram | drug interactions | The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [ see Clinical Pharmacology ( 12.3 ) ]. |
| Naltrexone | drug interactions | The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [ see Clinical Pharmacology ( 12.3 ) ]. |
Source: FDA drug label (ACAMPROSATE CALCIUM), Somerset Therapeutics, LLC, effective July 14, 2026 (SPL set 1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5), via openFDA; the full label on DailyMed
What do FAERS reports show for acamprosate?
The FDA Adverse Event Reporting System holds 322 reports that list acamprosate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 37 are coded as a death and 148 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acamprosate?
2 other medicines are given the same way (oral) and in the same FDA class as acamprosate or labeled mainly for the same use (alcohol use disorder), the same class first. Alcohol use disorder lists all 5 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Naltrexone | Alcohol use disorder | 21 labelers | $1.14 per tablet 50 mg tablet | No current entry |
| Disulfiram | Alcohol use disorder | 5 labelers | $1.82 per tablet 250 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does acamprosate compare with medicines for the same use?
1 side-by-side page set acamprosate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Acamprosate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other