Venlafaxine Hydrochloride Capsule, Extended Release
NDC Package 70518-4151-0

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

Package Information

Venlafaxine Hydrochloride capsules is venlafaxine Hydrochloride Extended-Release Capsules, USP are indicated in adults for the treatment of:Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] Panic Disorder (PD) [see Clinical Studies (14.4)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4151 and is authorized under FDA application ANDA214654.

Identification & Billing

NDC Package Code
70518-4151-0
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
70518-4151
11-Digit Billing Format
70518415100
RxNorm Crosswalk
  • RxCUI: 313585 - venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule
  • RxCUI: 313585 - 24 HR venlafaxine 75 MG Extended Release Oral Capsule
  • RxCUI: 313585 - venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Venlafaxine Hydrochloride
Non-Proprietary Name
Venlafaxine Hydrochloride
Substance Name
Venlafaxine Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a 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 Hydrochloride Extended-Release Capsules, USP are indicated in adults for the treatment of:Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] Panic Disorder (PD) [see Clinical Studies (14.4)]

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214654
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-29-2024
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 70518-4151-0 identifies a specific commercial package of 30 capsule, extended release in 1 blister pack of Venlafaxine Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. This capsule, 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 July 29, 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: 70518415100. 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)
70518-4151-0
11-Digit CMS (5-4-2)
70518-4151-00

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