Amitiza
NDC Package 35356-500-60
Package Information
Amitiza is a medication used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Marketed by Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 35356-500 and is authorized under FDA application NDA021908.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 35356 - Lake Erie Medical Dba Quality Care Products Llc
- 35356-500 - Amitiza
- 35356-500-60 - 60 CAPSULE, GELATIN COATED in 1 BOTTLE
- 35356-500 - Amitiza
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 35356-500-60 identifies a specific commercial package of 60 capsule, gelatin coated in 1 bottle of Amitiza, labeled by Lake Erie Medical Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lake Erie Medical Dba Quality Care Products Llc on June 01, 2011. The current certification is valid through January 31, 2025.
What are the primary indications for this medication?
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.
How is this Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 35356050060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.