Accutane
NDC Package 0004-0169-49

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.

Accutane is a . Marketed by Genentech, Inc., this product is identified by NDC 0004-0169 and is authorized under FDA application NDA018662.

Identification & Billing

NDC Package Code
0004-0169-49
Package Description
10 BLISTER PACK in 1 PACKAGE / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
0004-0169
11-Digit Billing Format
00004016949

Clinical Specifications

Proprietary Name
Accutane
Dosage Form
-

Regulatory & Marketing

Labeler Name
Genentech, Inc.
FDA Application #
NDA018662
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-07-1982
End Marketing Date
12-22-2010
Listing Expiration
12-22-2010
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 0004-0169-49 identifies a specific commercial package of 10 blister pack in 1 package / 10 capsule, liquid filled in 1 blister pack of Accutane, labeled by Genentech, 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 Genentech, Inc. on May 07, 1982. The current certification is valid through December 22, 2010.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00004016949. 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 (4-4-2)
0004-0169-49
11-Digit CMS (5-4-2)
00004-0169-49

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