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  4. NDC Product Code: 42799-962 Venlafaxine Hydrochloride, Extended Release

NDC 42799-962 Venlafaxine Hydrochloride, Extended Release

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 42799-962?
  5. Venlafaxine Hydrochloride, Extended Release Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 42799-962 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
42799-962
Proprietary Name:
Venlafaxine Hydrochloride, Extended Release
Product Type: [3]
Labeler Name: [5]
Edenbridge Pharmaceuticals Llc.
Labeler Code:
42799
Product Label ID:
38431a76-6185-4c17-994f-8278b6cd7510
FDA Application Number: [6]
ANDA209193
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
03-15-2023
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - IMPRINT IN BLUE)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
150MG
Score:
1

Code Structure Chart

Product Details

What is NDC 42799-962?

The NDC code 42799-962 is assigned by the FDA to the product Venlafaxine Hydrochloride, Extended Release which is product labeled by Edenbridge Pharmaceuticals Llc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 42799-962-01 30 tablet in 1 bottle , 42799-962-02 90 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Venlafaxine Hydrochloride, Extended Release?

Venlafaxine Hydrochloride 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.

Which are Venlafaxine Hydrochloride, Extended Release UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Venlafaxine Hydrochloride, Extended Release Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Venlafaxine Hydrochloride, Extended Release?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".