Desvenlafaxine Tablet, Film Coated, Extended Release
NDC Package 0054-0401-06

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

Package Information

Desvenlafaxine tablets is desvenlafaxine is used to treat depression. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0401 and is authorized under FDA application ANDA204083.

Identification & Billing

NDC Package Code
0054-0401-06
Package Description
14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
0054-0401
11-Digit Billing Format
00054040106
RxNorm Crosswalk
  • RxCUI: 1607617 - desvenlafaxine succinate 25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1607617 - 24 HR desvenlafaxine succinate 25 MG Extended Release Oral Tablet
  • RxCUI: 1607617 - desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral Tablet
  • RxCUI: 1874553 - desvenlafaxine succinate 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1874553 - 24 HR desvenlafaxine succinate 100 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Desvenlafaxine
Non-Proprietary Name
Desvenlafaxine
Substance Name
Desvenlafaxine Succinate
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DESVENLAFAXINE SUCCINATE 100 mg/1
Pharmacologic Class
Usage Information
Desvenlafaxine is used to treat depression. It may improve your mood, feelings of well-being, and energy level. Desvenlafaxine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204083
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0054-0401). Click a package code to view its specific billing and regulatory data.

0054-0401-13
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
0054-0401-20
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
0054-0401-22
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* 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 0054-0401-06 identifies a specific commercial package of 14 tablet, film coated, extended release in 1 bottle of Desvenlafaxine, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This tablet, film coated, extended release is formulated for oral use and contains desvenlafaxine succinate 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 Hikma Pharmaceuticals Usa Inc. on March 01, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Desvenlafaxine is used to treat depression. It may improve your mood, feelings of well-being, and energy level. Desvenlafaxine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054040106. 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)
0054-0401-06
11-Digit CMS (5-4-2)
00054-0401-06

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