Lansoprazole
NDC 55700-616
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Lansoprazole is a ANDA-approved product labeled by Lake Erie Medical Dba Quality Care Products Llc. Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It is supplied as a product. This product entry covers the primary NDC 55700-616 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
55700-616
Proprietary Name:
Lansoprazole
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
55700
FDA Application Number: [6]
ANDA202366
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
05-04-2018
End Marketing Date: [10]
08-31-2020
Listing Expiration Date: [11]
08-31-2020
Exclude Flag: [12]
D
Code Structure Chart
Patient Education
Lansoprazole
Prescription lansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription lansoprazole is used to treat the damage from GERD in adults and children 1 year of age and older. Prescription lansoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription lansoprazole is also used to treat ulcers (sores in the lining of the stomach or intestine), to prevent more ulcers from developing in adults whose ulcers have already healed, and to decrease the risk that adults who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers. Prescription lansoprazole is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Prescription lansoprazole is also used in combination with other medications to treat and prevent stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) lansoprazole is used to treat frequent heartburn (heartburn that occurs two or more days per week) in adults. Lansoprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
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Lansoprazole, Clarithromycin, and Amoxicillin
Lansoprazole, clarithromycin, and amoxicillin are used to treat and prevent the return of ulcers (sores in the lining of the stomach or intestine) caused by a certain type of bacteria (H. pylori). Lansoprazole is in a class of medications called proton pump inhibitors. Clarithromycin and amoxicillin are in a class of medications called antibiotics. Lansoprazole works by decreasing the amount of acid made in the stomach. Clarithromycin and amoxicillin work by stopping the growth of the bacteria that may cause ulcers. Antibiotics will not work for colds, flu, or other viral infections.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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 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".
