Venlafaxine Hydrochloride Tablet, Extended Release
NDC Package 70518-4065-0

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

Package Information

Venlafaxine Hydrochloride (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 [ seeClinical Studies ( 14.1) ]. This formulation utilizes a tablet, extended release delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4065 and is authorized under FDA application ANDA216044.

Identification & Billing

NDC Package Code
70518-4065-0
Package Description
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
70518-4065
11-Digit Billing Format
70518406500
RxNorm Crosswalk
  • RxCUI: 808753 - venlafaxine HCl 75 MG 24HR Extended Release Oral Tablet
  • RxCUI: 808753 - 24 HR venlafaxine 75 MG Extended Release Oral Tablet
  • RxCUI: 808753 - venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet
  • RxCUI: 808753 - venlafaxine 75 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Venlafaxine Hydrochloride
Non-Proprietary Name
Venlafaxine
Substance Name
Venlafaxine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VENLAFAXINE HYDROCHLORIDE 75 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 [ seeClinical 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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216044
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-04-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-4065-0 identifies a specific commercial package of 90 tablet, extended release in 1 bottle, plastic of Venlafaxine Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. This tablet, extended release 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 Remedyrepack Inc. on May 04, 2024. The current certification is valid through December 31, 2026.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518406500. 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)
70518-4065-0
11-Digit CMS (5-4-2)
70518-4065-00

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