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  4. NDC Product Code: 0187-4100 Librax

NDC 0187-4100 Librax

Chlordiazepoxide Hydrochloride And Clidinium Bromide Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0187-4100?
  5. Librax Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
0187-4100
Proprietary Name:
Librax
Non-Proprietary Name: [1]
Chlordiazepoxide Hydrochloride And Clidinium Bromide
Substance Name: [2]
Chlordiazepoxide Hydrochloride; Clidinium Bromide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Bausch Health Us, Llc
    Labeler Code:
    0187
    Product Label ID:
    f99ebf66-f207-4a97-9666-4da1d72b061c
    FDA Application Number: [6]
    NDA012750
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-01-1966
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329 - LIGHT)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    Imprint(s):
    LIBRAX
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0187-4100?

    The NDC code 0187-4100 is assigned by the FDA to the product Librax which is a human prescription drug product labeled by Bausch Health Us, Llc. The generic name of Librax is chlordiazepoxide hydrochloride and clidinium bromide. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 0187-4100-10 100 capsule 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 Librax?

    This medication is a combination of 2 drugs, clidinium and chlordiazepoxide. It is used along with other medications to help treat stomach/intestinal disorders (such as ulcers, irritable bowel syndrome, bowel infections). Clidinium helps to reduce the symptoms of stomach and intestinal cramping. It works by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Clidinium belongs to a class of drugs known as anticholinergics/antispasmodics. Chlordiazepoxide helps to reduce anxiety. It acts on the brain and nerves to produce a calming effect. It belongs to a class of drugs known as benzodiazepines.

    What are Librax Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Librax UNII Codes?

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

    Which are Librax 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 Librax?

    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
    • RxCUI: 889616 - Librax 5 MG / 2.5 MG Oral Capsule
    • RxCUI: 889616 - chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule [Librax]
    • RxCUI: 889616 - Librax (chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG) Oral Capsule

    Which are the Pharmacologic Classes for Librax?

    * 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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [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 ("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".