Fetzima Kit
NDC Package 0456-2202-28

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

Package Information

Fetzima (levomilnacipran hydrochloride) kits is levomilnacipran is used to treat depression. This formulation utilizes a kit delivery system. Marketed by Allergan, Inc., this product is identified by NDC 0456-2202 and is authorized under FDA application NDA204168.

Identification & Billing

NDC Package Code
0456-2202-28
Package Description
1 KIT in 1 BLISTER PACK
Product Code
0456-2202
11-Digit Billing Format
00456220228
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1433217 - levomilnacipran 120 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1433217 - 24 HR levomilnacipran 120 MG Extended Release Oral Capsule
  • RxCUI: 1433217 - levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG) 24 HR Extended Release Oral Capsule
  • RxCUI: 1433223 - Fetzima 120 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1433223 - 24 HR levomilnacipran 120 MG Extended Release Oral Capsule [Fetzima]

Clinical Specifications

Proprietary Name
Fetzima
Non-Proprietary Name
Levomilnacipran Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Levomilnacipran is used to treat depression. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. Levomilnacipran belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It may improve your mood, sleep, and appetite and may help restore your interest in daily living.

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204168
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-25-2013
Listing Expiration
12-31-2027
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 0456-2202-28 identifies a specific commercial package of 1 kit in 1 blister pack of Fetzima, a human prescription drug labeled by Allergan, Inc.. This kit is formulated for oral use and contains 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 Allergan, Inc. on July 25, 2013. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Levomilnacipran is used to treat depression. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. Levomilnacipran belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It may improve your mood, sleep, and appetite and may help restore your interest in daily living.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00456220228. 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 (4-4-2)
0456-2202-28
11-Digit CMS (5-4-2)
00456-2202-28

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