Venlafaxine Tablet, Coated
NDC Package 71209-088-04

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

Venlafaxine tablets is venlafaxine extended-release tablets 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. This formulation utilizes a tablet, coated delivery system. Marketed by Cadila Pharmaceuticals Limited, this product is identified by NDC 71209-088 and is authorized under FDA application ANDA211323.

Identification & Billing

NDC Package Code
71209-088-04
Package Description
90 TABLET, COATED in 1 BOTTLE
Product Code
71209-088
11-Digit Billing Format
71209008804
RxNorm Crosswalk
  • RxCUI: 808744 - venlafaxine HCl 150 MG 24HR Extended Release Oral Tablet
  • RxCUI: 808744 - 24 HR venlafaxine 150 MG Extended Release Oral Tablet
  • RxCUI: 808744 - venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet
  • RxCUI: 808744 - venlafaxine 150 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 808748 - venlafaxine HCl 225 MG 24HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Venlafaxine
Non-Proprietary Name
Venlafaxine
Substance Name
Venlafaxine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VENLAFAXINE HYDROCHLORIDE 150 mg/1
Pharmacologic Class
Usage Information
Venlafaxine extended-release tablets 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
Cadila Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA211323
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-05-2018
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 (71209-088). Click a package code to view its specific billing and regulatory data.

71209-088-01
30 TABLET, COATED in 1 BOTTLE
71209-088-11
1000 TABLET, COATED 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 71209-088-04 identifies a specific commercial package of 90 tablet, coated in 1 bottle of Venlafaxine, a human prescription drug labeled by Cadila Pharmaceuticals Limited. This tablet, coated is formulated for oral use and contains venlafaxine 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 Cadila Pharmaceuticals Limited on January 05, 2018. The current certification is valid through December 31, 2026.

How is this Cadila Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71209008804. 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)
71209-088-04
11-Digit CMS (5-4-2)
71209-0088-04

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