Ocaliva
NDC Package 69516-005-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ocaliva is a medication used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). Marketed by Intercept Pharmaceuticals Inc, this product is identified by NDC 69516-005 and is authorized under FDA application NDA207999.

Identification & Billing

NDC Package Code
69516-005-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
69516-005
11-Digit Billing Format
69516000530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Ocaliva
Dosage Form
-
Usage Information
This medication is used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver. When bile ducts are damaged, harmful substances can build up in bile and scar the liver. Obeticholic acid works by causing your liver to make less bile, and by helping bile flow out of the liver. Obeticholic acid may help slow worsening of primary biliary cholangitis and decrease symptoms such as tiredness, itchy skin, abdominal pain, and dry eyes and mouth.

Regulatory & Marketing

Labeler Name
Intercept Pharmaceuticals Inc
FDA Application #
NDA207999
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-27-2016
End Marketing Date
11-14-2025
Listing Expiration
11-14-2025
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69516-005-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Ocaliva, labeled by Intercept Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Intercept Pharmaceuticals Inc on May 27, 2016. The current certification is valid through November 14, 2025.

What are the primary indications for this medication?

This medication is used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver. When bile ducts are damaged, harmful substances can build up in bile and scar the liver. Obeticholic acid works by causing your liver to make less bile, and by helping bile flow out of the liver. Obeticholic acid may help slow worsening of primary biliary cholangitis and decrease symptoms such as tiredness, itchy skin, abdominal pain, and dry eyes and mouth.

How is this Intercept Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69516000530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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:

10-Digit Format (5-3-2)
69516-005-30
11-Digit CMS (5-4-2)
69516-0005-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.