Phenelzine Sulfate Tablet
NDC Package 43386-360-21

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

Package Information

Phenelzine Sulfate tablets is phenelzine is an antidepressant (monoamine oxidase inhibitor). This formulation utilizes a tablet delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-360 and is authorized under FDA application ANDA200181.

Identification & Billing

NDC Package Code
43386-360-21
Package Description
60 TABLET in 1 BOTTLE
Product Code
43386-360
11-Digit Billing Format
43386036021
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phenelzine Sulfate
Non-Proprietary Name
Phenelzine Sulfate
Substance Name
Phenelzine Sulfate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENELZINE SULFATE 15 mg/1
Pharmacologic Class
Usage Information
Phenelzine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Phenelzine 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
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200181
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-14-2010
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 43386-360-21 identifies a specific commercial package of 60 tablet in 1 bottle of Phenelzine Sulfate, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This tablet is formulated for oral use and contains phenelzine 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 Lupin Pharmaceuticals,inc. on December 14, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Phenelzine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Phenelzine 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 Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386036021. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
43386-360-21
11-Digit CMS (5-4-2)
43386-0360-21

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