NDC 43598-883-52 Lansoprazole

Lansoprazole

NDC Package Code 43598-883-52

The NDC Code 43598-883-52 is assigned to a package of 1 bottle in 1 carton > 14 capsule, delayed release in 1 bottle of Lansoprazole, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is capsule, delayed release and is administered via oral form.

Field Name Field Value
NDC Code 43598-883-52
Package Description 1 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Proprietary Name Lansoprazole What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Lansoprazole 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.
Drug Uses Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Lansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter lansoprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
11-Digit NDC Billing Format 43598088352 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Otc Drug 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.
Labeler Name Dr. Reddy's Laboratories Inc.
Dosage Form Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • LANSOPRAZOLE 15 mg/1
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
FDA Application Number ANDA202194 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.
Start Marketing Date 08-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2020 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.
Exclude Flag N 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. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 43598 - Dr. Reddy's Laboratories Inc.
    • 43598-883 - Lansoprazole
      • 43598-883-52 - 1 BOTTLE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Lansoprazole with product NDC 43598-883.

NDC Package CodePackage Description
43598-883-423 BOTTLE in 1 CARTON > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

* Please review the disclaimer below.