Savella Tablet, Film Coated
NDC Package 55154-4626-8

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

Package Information

Savella (milnacipran hydrochloride) tablets is milnacipran is used to treat pain caused by a condition called fibromyalgia that affects the muscles, tendons, ligaments, and supporting tissues. This formulation utilizes a tablet, film coated delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-4626 and is authorized under FDA application NDA022256.

Identification & Billing

NDC Package Code
55154-4626-8
Package Description
1920 TABLET, FILM COATED in 1 BOTTLE
Product Code
55154-4626
11-Digit Billing Format
55154462608
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Savella
Non-Proprietary Name
Milnacipran Hydrochloride
Substance Name
Milnacipran Hydrochloride
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)
MILNACIPRAN HYDROCHLORIDE 50 mg/1
Pharmacologic Class
Usage Information
Milnacipran is used to treat pain caused by a condition called fibromyalgia that affects the muscles, tendons, ligaments, and supporting tissues. This medication is a serotonin-norepinephrine reuptake inhibitor (SNRI) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022256
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-17-2009
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 55154-4626-8 identifies a specific commercial package of 1920 tablet, film coated in 1 bottle of Savella, a human prescription drug labeled by Cardinal Health 107, Llc. This tablet, film coated is formulated for oral use and contains milnacipran hydrochloride 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 Cardinal Health 107, Llc on April 17, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Milnacipran is used to treat pain caused by a condition called fibromyalgia that affects the muscles, tendons, ligaments, and supporting tissues. This medication is a serotonin-norepinephrine reuptake inhibitor (SNRI) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154462608. 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 (5-4-1)
55154-4626-8
11-Digit CMS (5-4-2)
55154-4626-08

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