acamprosate calcium enteric-coated
acamprosate calcium enteric-coated is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Acamprosate Calcium. Available dosage form: tablet, delayed release.
Drug Details
- Generic Name
- acamprosate calcium enteric-coated
- Brand Names
- Acamprosate Calcium
- Application Number
- ANDA200142
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- ACAMPROSATE CALCIUM
Indications and Usage
1 INDICATIONS AND USAGE Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation (1, 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support (1).