Acamprosate Calcium Tablet, Delayed Release
NDC Package 0904-7213-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Major Pharmaceuticals, this product is identified by NDC 0904-7213 and is authorized under FDA application ANDA202229.

Identification & Billing

NDC Package Code
0904-7213-04
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
0904-7213
11-Digit Billing Format
00904721304
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 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
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
Major Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA202229
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-16-2013
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 0904-7213-04 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack of Acamprosate Calcium, a human prescription drug labeled by Major Pharmaceuticals. 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 Major Pharmaceuticals on July 16, 2013. The current certification is valid through December 31, 2027.

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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904721304. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
0904-7213-04
11-Digit CMS (5-4-2)
00904-7213-04

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