NDC 64116-121 Esbriet

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:
64116-121
Proprietary Name:
Esbriet
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
64116
Start Marketing Date: [9]
10-16-2014
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
INTERMUNE;267;MG
Score:
1

Code Structure Chart

Product Details

What is NDC 64116-121?

The NDC code 64116-121 is assigned by the FDA to the product Esbriet which is product labeled by Intermune, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 64116-121-01 1 bottle, plastic in 1 carton / 270 capsule in 1 bottle, plastic, 64116-121-02 1 blister pack in 1 carton / 63 capsule in 1 blister pack, 64116-121-03 4 blister pack in 1 carton / 63 capsule 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 Esbriet?

Pirfenidone is used to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). This disease causes the lungs to get scarred and become stiff, making it hard to breathe. Pirfenidone may help slow down the worsening of your IPF.

Which are Esbriet UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Esbriet?

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".