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  4. NDC Product Code: 42582-301 Chlordiazepoxide Hydrochloride And Clidinium Bromide

NDC 42582-301 Chlordiazepoxide Hydrochloride And Clidinium Bromide

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 42582-301?
  5. Chlordiazepoxide Hydrochloride And Clidinium Bromide 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.

Get all the details for National Drug Code (NDC) 42582-301 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
42582-301
Proprietary Name:
Chlordiazepoxide Hydrochloride And Clidinium Bromide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Bi-coastal Pharma International Limited Liability Company
Labeler Code:
42582
Product Label ID:
d8dd70f1-b9b3-4a6a-be09-73913d1a7e51
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
05-04-2011
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
200
Score:
1

Code Structure Chart

Product Details

What is NDC 42582-301?

The NDC code 42582-301 is assigned by the FDA to the product Chlordiazepoxide Hydrochloride And Clidinium Bromide which is product labeled by Bi-coastal Pharma International Limited Liability Company. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 42582-301-10 100 capsule in 1 bottle, plastic , 42582-301-16 250 capsule in 1 bottle, plastic , 42582-301-20 1000 capsule in 1 bottle, plastic . 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide?

Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows:"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.Final classification of the less-than-effective indications requires further investigation.

Which are Chlordiazepoxide Hydrochloride And Clidinium Bromide UNII Codes?

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

Which are Chlordiazepoxide Hydrochloride And Clidinium Bromide 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 Chlordiazepoxide Hydrochloride And Clidinium Bromide?

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: 889614 - chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral Capsule
  • RxCUI: 889614 - chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule

* Please review the disclaimer below.

Patient Education

Chlordiazepoxide and Clidinium


The combination of chlordiazepoxide and clidinium is used along with other medications to treat peptic ulcers, irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea), and enterocolitis (swelling in the intestines). Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain. Clidinium is in a class of medications called anticholinergics. It helps to decrease stomach spasms and cramps.
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* 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.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".