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  5. NDC Package Code: 69516-005-30 Ocaliva

NDC Package 69516-005-30 Ocaliva

Obeticholic Acid Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69516-005-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
69516-005
Proprietary Name:
Ocaliva
Non-Proprietary Name:
Obeticholic Acid
Substance Name:
Obeticholic Acid
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.
11-Digit NDC Billing Format:
69516000530
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1798364 - obeticholic acid 5 MG Oral Tablet
  • RxCUI: 1798370 - OCALIVA 5 MG Oral Tablet
  • RxCUI: 1798370 - obeticholic acid 5 MG Oral Tablet [Ocaliva]
  • RxCUI: 1798370 - Ocaliva 5 MG Oral Tablet
  • RxCUI: 1798373 - obeticholic acid 10 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Intercept Pharmaceuticals Inc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • OBETICHOLIC ACID 5 mg/1
    • Pharmacologic Class(es):
  • Farnesoid X Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Farnesoid X Receptor Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA207999
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-27-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 69516-005-30?

    The NDC Packaged Code 69516-005-30 is assigned to a package of 30 tablet, film coated in 1 bottle, plastic of Ocaliva, a human prescription drug labeled by Intercept Pharmaceuticals Inc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 69516-005 included in the NDC Directory?

    Yes, Ocaliva with product code 69516-005 is active and included in the NDC Directory. The product was first marketed by Intercept Pharmaceuticals Inc on May 27, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 69516-005-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 69516-005-30?

    The 11-digit format is 69516000530. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269516-005-305-4-269516-0005-30