Lumacaftor/ivacaftor Paediatric Tablet, Film Coated
NDC 43798-014

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 43798-014?
  4. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Lumacaftor/ivacaftor Paediatric is a DRUG FOR FURTHER PROCESSING-approved product labeled by Aesica Queenborough Limited. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a tablet, film coated. This product entry covers the primary NDC 43798-014 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43798-014
Proprietary Name:
Lumacaftor/ivacaftor Paediatric
Non-Proprietary Name: [1]
Lumacaftor/ivacaftor Paediatric
Substance Name: [2]
Ivacaftor; Lumacaftor
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Labeler & Regulatory Data

Labeler Name: [5]
Aesica Queenborough Limited
Labeler Code:
43798
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.

Marketing Timeline

Start Marketing Date: [9]
11-29-2017
End Marketing Date: [10]
10-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes

Code Structure Chart

Product Details

What is NDC 43798-014?

The NDC code 43798-014 is assigned by the FDA to the product Lumacaftor/ivacaftor Paediatric. It is commonly known by its generic name, lumacaftor/ivacaftor paediatric. This pharmaceutical product is labeled by Aesica Queenborough Limited and is currently categorized as listed product. The medication is a tablet, film coated. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 43798-014-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are Active Ingredients of this product?

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.

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Product & Regulatory Definitions
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.
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.
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.
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.