NDC Package 43602-392-05 Venlafaxine Hydrochloride

Venlafaxine Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43602-392-05
Package Description:
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Venlafaxine Hydrochloride
Non-Proprietary Name:
Venlafaxine
Substance Name:
Venlafaxine Hydrochloride
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.
11-Digit NDC Billing Format:
43602039205
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ascent Pharmaceuticals, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA214419
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-23-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43602-392-3030 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43602-392-05?

    The NDC Packaged Code 43602-392-05 is assigned to a package of 500 tablet, extended release in 1 bottle of Venlafaxine Hydrochloride, a human prescription drug labeled by Ascent Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 43602-392 included in the NDC Directory?

    Yes, Venlafaxine Hydrochloride with product code 43602-392 is active and included in the NDC Directory. The product was first marketed by Ascent Pharmaceuticals, Inc. on October 23, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 43602-392-05?

    The 11-digit format is 43602039205. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243602-392-055-4-243602-0392-05