Acamprosate Calcium Tablet, Delayed Release
NDC Package 0378-6333-80

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

Package Information

Acamprosate Calcium (acamprosate calcium enteric-coated) 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 Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-6333 and is authorized under FDA application ANDA200142.

Identification & Billing

NDC Package Code
0378-6333-80
Package Description
180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
0378-6333
11-Digit Billing Format
00378633380
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
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 Enteric-coated
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200142
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-24-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-6333-80 identifies a specific commercial package of 180 tablet, delayed release in 1 bottle, plastic of Acamprosate Calcium, a human prescription drug labeled by Mylan Pharmaceuticals 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 Mylan Pharmaceuticals Inc. on September 24, 2014. 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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378633380. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 total billable units per package. 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 (4-4-2)
0378-6333-80
11-Digit CMS (5-4-2)
00378-6333-80

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