NDC 57297-410 Irbesartan

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:
57297-410
Proprietary Name:
Irbesartan
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lupin Limited
Labeler Code:
57297
Start Marketing Date: [9]
10-23-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
11 MM
Imprint(s):
LU;M11
Score:
1

Product Packages

NDC Code 57297-410-06

Package Description: 30 TABLET in 1 BOTTLE

NDC Code 57297-410-09

Package Description: 90 TABLET in 1 BOTTLE

Product Details

What is NDC 57297-410?

The NDC code 57297-410 is assigned by the FDA to the product Irbesartan which is product labeled by Lupin Limited. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 57297-410-06 30 tablet in 1 bottle , 57297-410-09 90 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 Irbesartan?

Irbesartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Irbesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.

Which are Irbesartan UNII Codes?

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

Which are Irbesartan 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 Irbesartan?

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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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".