Acamprosate Calcium Tablet, Delayed Release
NDC Package 50268-028-13

11-digit billing NDC: 50268002813
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Acamprosate Calcium tablets is 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. This formulation utilizes a tablet, delayed release delivery system. Marketed by Avpak, this product is identified by NDC 50268-028 and is authorized under FDA application ANDA219904.

Identification & Billing

NDC Package Code
50268-028-13
Package Description
30 BLISTER PACK in 1 BOX / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-028-11)
Product Code
50268-028
11-Digit Billing Format
50268002813

Clinical Specifications

Proprietary Name
Acamprosate Calcium
Non-Proprietary Name
Acamprosate Calcium
Substance Name
Acamprosate Calcium
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACAMPROSATE CALCIUM 333 mg/1
Usage Information
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.

Regulatory & Marketing

Labeler Name
Avpak
Product Type
Human Prescription Drug
FDA Application #
ANDA219904
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50268-028-13 identifies a specific commercial package of 30 blister pack in 1 box / 1 tablet, delayed release in 1 blister pack (50268-028-11) of Acamprosate Calcium, a human prescription drug labeled by Avpak. This tablet, delayed release is formulated for oral use and contains acamprosate calcium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avpak on October 26, 2026. The current certification is valid through December 31, 2027.

How is this Avpak product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50268002813. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50268-028-13
11-Digit CMS (5-4-2)
50268-0028-13

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.