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  4. NDC Product Code: 10135-636 Acamprosate Calcium

NDC 10135-636 Acamprosate Calcium

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10135-636?
  5. Acamprosate Calcium Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
10135-636
Proprietary Name:
Acamprosate Calcium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Product Label ID:
a815699f-90ee-41ba-838c-11951aeda90f
Start Marketing Date: [9]
08-01-2016
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
435
Score:
1

Code Structure Chart

Product Details

What is NDC 10135-636?

The NDC code 10135-636 is assigned by the FDA to the product Acamprosate Calcium which is product labeled by Marlex Pharmaceuticals Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10135-636-32 180 tablet, delayed release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Acamprosate Calcium?

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.

Which are Acamprosate Calcium UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Acamprosate Calcium Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Acamprosate Calcium?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 835726 - acamprosate calcium 333 MG Delayed Release Oral Tablet
  • RxCUI: 835726 - acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet

* Please review the disclaimer below.

Patient Education

Acamprosate


Acamprosate is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol (alcoholism) to avoid drinking alcohol again. Drinking alcohol for a long time changes the way the brain works. Acamprosate works by helping the brains of people who have drunk large amounts of alcohol to work normally again. Acamprosate does not prevent the withdrawal symptoms that people may experience when they stop drinking alcohol. Acamprosate has not been shown to work in people who have not stopped drinking alcohol or in people who drink large amounts of alcohol and also overuse or abuse other substances such as street drugs or prescription medications.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".