Acamprosate Calcium Tablet, Delayed Release
NDC Package 68382-569-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Acamprosate Calcium tablets is a medication used along with counseling and support to help people who are alcohol dependent not drink alcohol. This formulation utilizes a tablet, delayed release delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-569 and is authorized under FDA application ANDA205995.

Identification & Billing

NDC Package Code
68382-569-06
Package Description
30 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
68382-569
11-Digit Billing Format
68382056906
RxNorm Crosswalk
  • RxCUI: 835726 - acamprosate calcium 333 MG Delayed Release Oral Tablet
  • RxCUI: 835726 - acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet

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
This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain (neurotransmitters). Before starting this medication, you should no longer be drinking alcohol. Acamprosate has not been shown to work well if you are still drinking alcohol when you start taking it.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205995
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2017
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68382-569). Click a package code to view its specific billing and regulatory data.

68382-569-01
100 TABLET, DELAYED RELEASE in 1 BOTTLE
68382-569-05
500 TABLET, DELAYED RELEASE in 1 BOTTLE
68382-569-10
1000 TABLET, DELAYED RELEASE in 1 BOTTLE
68382-569-16
90 TABLET, DELAYED RELEASE in 1 BOTTLE
68382-569-28
180 TABLET, DELAYED RELEASE in 1 BOTTLE

* 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 68382-569-06 identifies a specific commercial package of 30 tablet, delayed release in 1 bottle of Acamprosate Calcium, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. 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 Zydus Pharmaceuticals (usa) Inc. on June 01, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain (neurotransmitters). Before starting this medication, you should no longer be drinking alcohol. Acamprosate has not been shown to work well if you are still drinking alcohol when you start taking it.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382056906. 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)
68382-569-06
11-Digit CMS (5-4-2)
68382-0569-06

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