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  4. NDC Product Code: 58914-112 Viokace

NDC 58914-112 Viokace

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58914-112?
  4. Viokace Uses
  5. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 58914-112 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:
58914-112
Proprietary Name:
Viokace
Product Type: [3]
Labeler Name: [5]
Allergan, Inc.
Labeler Code:
58914
FDA Application Number: [6]
BLA022542
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
03-01-2012
End Marketing Date: [10]
04-30-2022
Listing Expiration Date: [11]
04-30-2022
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Patient Education

Pancrelipase


Pancrelipase capsules are used to improve digestion of food in infants, children, and adults who have pancreatic insufficiency (a condition in which the pancreas does not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food). Pancrelipase tablets are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who cannot digest food normally because they have chronic pancreatitis (swelling of the pancreas) or have had surgery to remove the pancreas. Pancrelipase is in a class of medications called enzymes. Pancrelipase acts in place of the enzymes normally made by the pancreas. It works to decrease fatty bowel movements and to improve nutrition by breaking down fats, proteins, and starches from food into smaller substances that can be absorbed from the intestine.
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Lipase


What is it? Lipase is an enzyme that breaks down fats during digestion. It is found in many plants, animals, bacteria, and molds. Some people use lipase as a medicine.

Since lipase breaks down fat into smaller pieces, it is possible that lipase supplements might make digestion easier.

Lipase is used for indigestion (dyspepsia), heartburn, and other gastrointestinal problems, but there is no good scientific evidence to support these uses.

Do not confuse lipase with pancreatic enzyme products. Pancreatic enzyme products contain multiple ingredients, including lipase. Some of these products are approved by the US FDA for digestion problems due to a disorder of the pancreas (pancreatic insufficiency).


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Product Footnotes

[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.

[10] 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.

[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".