NDC 65483-894 Lotronex

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
65483-894
Proprietary Name:
Lotronex
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Prometheus Laboratories Inc.
Labeler Code:
65483
Start Marketing Date: [9]
02-09-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape:
OVAL (C48345)
Size(s):
11 MM
Imprint(s):
GX;EX1
Score:
1

Product Packages

NDC Code 65483-894-03

Package Description: 30 TABLET in 1 BOTTLE

Price per Unit: $28.65404 per EA

Product Details

What is NDC 65483-894?

The NDC code 65483-894 is assigned by the FDA to the product Lotronex which is product labeled by Prometheus Laboratories Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 65483-894-03 30 tablet in 1 bottle . 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 Lotronex?

Alosetron is used to treat women with severe irritable bowel syndrome (IBS) who have diarrhea as the main problem. It is not a cure, but it may help to decrease abdominal pain, sudden urges to have a bowel movement, and diarrhea. This medication is not recommended for use by children because of the serious side effects that have been seen in adults.

Which are Lotronex UNII Codes?

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

Which are Lotronex 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 Lotronex?

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:

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".