Lazanda
NDC Package 13913-009-01

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.

Lazanda is see also Warning section. Marketed by Depomed, Inc., this product is identified by NDC 13913-009 and is authorized under FDA application NDA022569.

Identification & Billing

NDC Package Code
13913-009-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 8 SPRAY in 1 BOTTLE, SPRAY
Product Code
13913-009
11-Digit Billing Format
13913000901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Lazanda
Dosage Form
-
Usage Information
See also Warning section. This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

Regulatory & Marketing

Labeler Name
Depomed, Inc.
FDA Application #
NDA022569
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-17-2011
End Marketing Date
11-22-2017
Listing Expiration
11-22-2017
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 13913-009-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 8 spray in 1 bottle, spray of Lazanda, labeled by Depomed, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Depomed, Inc. on October 17, 2011. The current certification is valid through November 22, 2017.

What are the primary indications for this medication?

See also Warning section. This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13913000901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
13913-009-01
11-Digit CMS (5-4-2)
13913-0009-01

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