Quick answers
- What is Acamprosate calcium used for?
- The FDA-approved label (Acamprosate Calcium, Somerset Therapeutics, LLC, July 14, 2026) says: “Acamprosate 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Acamprosate calcium have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Acamprosate calcium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Acamprosate calcium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Acamprosate calcium?
- 11 companies list prescription products of Acamprosate calcium in the FDA NDC Directory, including NCS HealthCare of KY, LLC dba Vangard Labs, Mylan Pharmaceuticals Inc. and Remedyrepack Inc..
What Acamprosate calcium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Acamprosate 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. …
— FDA label: Acamprosate Calcium, Somerset Therapeutics, LLC, effective July 14, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 12 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acamprosate calcium 333 mg tablet, delayed release | Generic | $0.5859 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Mylan Pharmaceuticals Inc.1 product
- Remedyrepack Inc.1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Major Pharmaceuticals1 product
- AvPAK1 product
- Bionpharma Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Somerset Therapeutics, LLC1 product
- Zydus Lifesciences Limited1 product
- American Health Packaging1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA202229Glenmark Pharms Ltd · July 16, 2013
- ANDA200142Mylan · March 11, 2014
- ANDA205995Zydus Pharms · May 26, 2017
- ANDA219904Bionpharma · September 18, 2025
- ANDA218984Somerset Theraps LLC · March 16, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 24, 2026 · Class II · Ongoing · D-0774-2026
Failed Dissolution Specifications
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80. — Mylan Pharmaceuticals Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 835726 |
|---|---|
| SPL set ID of the quoted label | 1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5 |
| FDA labels (SPL) | 9 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | ACAMPROSATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Acamprosate Calcium, Somerset Therapeutics, LLC, effective July 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →