Venlafaxine
NDC Package 33261-679-30
Package Information
Venlafaxine is tablets, USP is indicated for the treatment of major depressive disorder.The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks);it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The efficacy of venlafaxine extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-679 and is authorized under FDA application ANDA078554.
Identification & Billing
- RxCUI: 313584 - venlafaxine HCl 37.5 MG Oral Tablet
- RxCUI: 313584 - venlafaxine 37.5 MG Oral Tablet
- RxCUI: 313584 - venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral Tablet
- RxCUI: 313586 - venlafaxine HCl 75 MG Oral Tablet
- RxCUI: 313586 - venlafaxine 75 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 33261 - Aidarex Pharmaceuticals Llc
- 33261-679 - Venlafaxine
- 33261-679-30 - 30 TABLET in 1 BOTTLE, PLASTIC
- 33261-679 - Venlafaxine
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 (33261-679). Click a package code to view its specific billing and regulatory data.
* 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 33261-679-30 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Venlafaxine, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Aidarex Pharmaceuticals Llc on November 30, 2012. The current certification is valid through December 31, 2019.
How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261067930. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
