Venlafaxine Hydrochloride
NDC Package 68025-080-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Venlafaxine Hydrochloride is venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD).Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [ see Clinical Studies (14.1)]. Marketed by Vertical Pharmaceuticals, Llc, this product is identified by NDC 68025-080 and is authorized under FDA application NDA022104.

Identification & Billing

NDC Package Code
68025-080-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68025-080
11-Digit Billing Format
68025008030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Venlafaxine Hydrochloride
Dosage Form
-
Usage Information
Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD).Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [ see Clinical Studies (14.1)]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Regulatory & Marketing

Labeler Name
Vertical Pharmaceuticals, Llc
FDA Application #
NDA022104
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
04-29-2010
End Marketing Date
05-31-2026
Listing Expiration
05-31-2026
Exclude Flag
D
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 68025-080-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Venlafaxine Hydrochloride, labeled by Vertical Pharmaceuticals, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Vertical Pharmaceuticals, Llc on April 29, 2010. The current certification is valid through May 31, 2026.

How is this Vertical Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68025008030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
68025-080-30
11-Digit CMS (5-4-2)
68025-0080-30

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