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  4. NDC Product Code: 35356-500 Amitiza

NDC 35356-500 Amitiza

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 35356-500?
  5. Amitiza Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
35356-500
Proprietary Name:
Amitiza
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lake Erie Medical Dba Quality Care Products Llc
Labeler Code:
35356
Product Label ID:
417aa15d-ac74-4fa8-a312-6e51e82ba70c
Start Marketing Date: [9]
06-01-2011
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
OVAL (C48345)
Size(s):
9 MM
Imprint(s):
SPI
Score:
1

Code Structure Chart

Product Details

What is NDC 35356-500?

The NDC code 35356-500 is assigned by the FDA to the product Amitiza which is product labeled by Lake Erie Medical Dba Quality Care Products Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 35356-500-60 60 capsule, gelatin coated 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 Amitiza?

This medication is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. This medication may improve symptoms such as bloating and abdominal discomfort, improve stool texture, lessen the need to strain, and decrease the feeling of not completely relieving oneself. Lubiprostone belongs to a class of drugs known as chloride channel activators. It works by increasing the amount of fluid within your intestines, making the passage of stool easier.

Which are Amitiza UNII Codes?

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

Which are Amitiza 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 Amitiza?

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

Lubiprostone


Lubiprostone is used to relieve stomach pain, bloating, and straining and produce softer and more frequent bowel movements in people who have chronic idiopathic constipation (difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Lubiprostone is also used 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) in women who are at least 18 years of age. Lubiprostone is also used to treat constipation caused by certain opioid (narcotic) pain medications in people with chronic (on-going), noncancer pain. Lubiprostone is in a class of medications called laxatives. It works by increasing the amount of fluid that flows into the bowel and allowing the stool to pass more easily.
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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".