Rifabutin
NDC Package 68180-285-01

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.

Rifabutin is a medication used alone or with another medication to help prevent a certain serious infection (Mycobacterium avium complex-MAC). Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-285 and is authorized under FDA application ANDA090033.

Identification & Billing

NDC Package Code
68180-285-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
68180-285
11-Digit Billing Format
68180028501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Rifabutin
Dosage Form
-
Usage Information
This medication is used alone or with another medication to help prevent a certain serious infection (Mycobacterium avium complex-MAC). Rifabutin is known as a rifamycin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats and prevents only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
FDA Application #
ANDA090033
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-26-2014
End Marketing Date
03-31-2021
Listing Expiration
03-31-2021
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 68180-285-01 identifies a specific commercial package of 100 capsule in 1 bottle of Rifabutin, labeled by Lupin Pharmaceuticals, Inc.. 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 Lupin Pharmaceuticals, Inc. on March 26, 2014. The current certification is valid through March 31, 2021.

What are the primary indications for this medication?

This medication is used alone or with another medication to help prevent a certain serious infection (Mycobacterium avium complex-MAC). Rifabutin is known as a rifamycin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats and prevents only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180028501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
68180-285-01
11-Digit CMS (5-4-2)
68180-0285-01

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