Lansoprazole Capsule, Delayed Release
NDC 33342-310

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 33342-310?
  5. Lansoprazole 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

Lansoprazole is a ANDA-approved product labeled by Macleods Pharmaceuticals Limited. Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It is supplied as a pink capsule, delayed release for oral administration. This product entry covers the primary NDC 33342-310 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
33342-310
Proprietary Name:
Lansoprazole
Non-Proprietary Name: [1]
Lansoprazole
Substance Name: [2]
Lansoprazole
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Macleods Pharmaceuticals Limited
Labeler Code:
33342
Product Label ID:
75691c2d-2265-4153-bc3a-4f7d5d51e250
FDA Application Number: [6]
ANDA208671
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-05-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
PINK (C48328 - OPAQUE PINK CAP)
GREEN (C48329 - OPAQUE GREEN BODY)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
C86;15MG
Score:
1

Code Structure Chart

Product Details

What is NDC 33342-310?

The NDC code 33342-310 is assigned by the FDA to the product Lansoprazole. This pharmaceutical product is labeled by Macleods Pharmaceuticals Limited and is currently categorized as listed product. The medication is a capsule, delayed release administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 33342-310-07. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

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.
  • LANSOPRAZOLE 15 mg/1 - A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

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.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 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".