Chlordiazepoxide Hydrochloride And Clidinium Bromide
NDC 42582-301

View dosage, usage, ingredients, routes, and UNII mappings.
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.

Chlordiazepoxide Hydrochloride And Clidinium Bromide is a UNAPPROVED DRUG OTHER-approved product labeled by Bi-coastal Pharma International Limited Liability Company. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 42582-301 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
42582-301
Proprietary Name:
Chlordiazepoxide Hydrochloride And Clidinium Bromide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
05-04-2011
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I

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. This pharmaceutical product is labeled by Bi-coastal Pharma International Limited Liability Company and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 42582-301-10, 42582-301-16, 42582-301-20. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".