NDC 45802-929 Mesalamine

Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
45802-929
Proprietary Name:
Mesalamine
Non-Proprietary Name: [1]
Mesalamine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Padagis Israel Pharmaceuticals Ltd
Labeler Code:
45802
FDA Application Number: [6]
ANDA076751
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
08-02-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF WHITE TO TAN)

Product Packages

NDC Code 45802-929-49

Package Description: 4 CARTON in 1 KIT / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET

Price per Unit: $116.13200 per EA

Product Details

What is NDC 45802-929?

The NDC code 45802-929 is assigned by the FDA to the product Mesalamine which is a human prescription drug product labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 45802-929-49 4 carton in 1 kit / 1 kit in 1 carton * 60 ml in 1 bottle (45802-098-46) * 1 swab in 1 packet. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Mesalamine?

This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

Which are Mesalamine UNII Codes?

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

Which are Mesalamine Inactive Ingredients 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 Mesalamine?

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:

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Patient Education

Mesalamine Rectal


Rectal mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon [last section of the colon]). Rectal mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.
[Learn More]


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Product Footnotes

[1] 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.

[3] 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.

[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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".