Tofranil
NDC Package 0028-0065-23

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.

Tofranil is a medication used to treat depression. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0028-0065 and is authorized under FDA application NDA011838.

Identification & Billing

NDC Package Code
0028-0065-23
Package Description
10 AMPULE in 1 BOX / 2 mL in 1 AMPULE
Product Code
0028-0065
11-Digit Billing Format
00028006523

Clinical Specifications

Proprietary Name
Tofranil
Dosage Form
-
Usage Information
This medication is used to treat depression. It is also used with other therapies for the treatment of nighttime bed-wetting (enuresis) in children. Using this medication to treat depression may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. Imipramine can help your child control nighttime bed-wetting. Imipramine belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (neurotransmitters such as norepinephrine) in the brain. For bed-wetting, this medication may work by blocking the effect of a certain natural substance (acetylcholine) on the bladder.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
FDA Application #
NDA011838
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-02-1959
End Marketing Date
09-12-2008
Listing Expiration
09-12-2008
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 0028-0065-23 identifies a specific commercial package of 10 ampule in 1 box / 2 ml in 1 ampule of Tofranil, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on October 02, 1959. The current certification is valid through September 12, 2008.

What are the primary indications for this medication?

This medication is used to treat depression. It is also used with other therapies for the treatment of nighttime bed-wetting (enuresis) in children. Using this medication to treat depression may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. Imipramine can help your child control nighttime bed-wetting. Imipramine belongs to a class of medications called tricyclic antidepressants. It works by restoring the balance of certain natural substances (neurotransmitters such as norepinephrine) in the brain. For bed-wetting, this medication may work by blocking the effect of a certain natural substance (acetylcholine) on the bladder.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00028006523. 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)
0028-0065-23
11-Digit CMS (5-4-2)
00028-0065-23

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