Tranylcypromine Sulfate Tablet, Film Coated
NDC Package 0591-5590-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tranylcypromine Sulfate tablets is tranylcypromine is an antidepressant (monoamine oxidase inhibitor). This formulation utilizes a tablet, film coated delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-5590 and is authorized under FDA application NDA012342.

Identification & Billing

NDC Package Code
0591-5590-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
0591-5590
11-Digit Billing Format
00591559001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tranylcypromine Sulfate
Non-Proprietary Name
Tranylcypromine Sulfate
Substance Name
Tranylcypromine Sulfate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRANYLCYPROMINE SULFATE 10 mg/1
Pharmacologic Class
Usage Information
Tranylcypromine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Tranylcypromine can improve your mood and feelings of well-being. Usually, this medication is used in persons who have not responded to treatment with other drugs.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA012342
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-05-2016
Listing Expiration
12-31-2026
Exclude Flag
N
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 0591-5590-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Tranylcypromine Sulfate, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet, film coated is formulated for oral use and contains tranylcypromine sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Actavis Pharma, Inc. on February 05, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tranylcypromine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Tranylcypromine can improve your mood and feelings of well-being. Usually, this medication is used in persons who have not responded to treatment with other drugs.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591559001. 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 (4-4-2)
0591-5590-01
11-Digit CMS (5-4-2)
00591-5590-01

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