NDC 0525-0971 Zelnorm

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:
0525-0971
Proprietary Name:
Zelnorm
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
0525
Start Marketing Date: [9]
08-01-2019
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
ZEL;6
Score:
1

Code Structure Chart

Product Details

What is NDC 0525-0971?

The NDC code 0525-0971 is assigned by the FDA to the product Zelnorm which is product labeled by Alfasigma Usa, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 0525-0971-10 1 blister pack in 1 carton / 10 tablet in 1 blister pack, 0525-0971-30 3 blister pack in 1 carton / 10 tablet in 1 blister pack, 0525-0971-60 6 blister pack in 1 carton / 10 tablet in 1 blister pack. 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 Zelnorm?

This medication is used by women to treat a certain stomach/intestinal disorder (irritable bowel syndrome with constipation, or IBS-C). Tegaserod works by speeding up the motion in your gut. This effect shortens the time stool remains in the bowel, and helps lessen symptoms such as belly pain and constipation. This medication has not been shown to work in men with IBS.

Which are Zelnorm UNII Codes?

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

Which are Zelnorm 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 Zelnorm?

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

Tegaserod


Tegaserod is used in women younger than 65 years of age to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools). Tegaserod is in a class of medications called serotonin agonists. It works by improving muscle movement and increasing production of fluid in the bowels.
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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".