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  4. NDC Product Code: 16714-044 Venlafaxine Hydrochloride

NDC 16714-044 Venlafaxine Hydrochloride

Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16714-044?
  5. Venlafaxine Hydrochloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
16714-044
Proprietary Name:
Venlafaxine Hydrochloride
Non-Proprietary Name: [1]
Venlafaxine Hydrochloride
Substance Name: [2]
Venlafaxine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Northstar Rx Llc.
    Labeler Code:
    16714
    Product Label ID:
    a67cfaab-0b73-4dcd-be29-e2fe0d6c93db
    FDA Application Number: [6]
    ANDA090174
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-10-2021
    End Marketing Date: [10]
    07-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    GRAY (C48324 - GRAY)
    WHITE (C48325 - WHITE)
    ORANGE (C48331 - PEACH)
    Shape:
    CAPSULE (C48336)
    Size(s):
    16 MM
    20 MM
    Imprint(s):
    ZA;35;37;5;MG
    ZA;36;75;MG
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 16714-044?

    The NDC code 16714-044 is assigned by the FDA to the product Venlafaxine Hydrochloride which is a human prescription drug product labeled by Northstar Rx Llc.. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 16714-044-01 90 capsule, extended release 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?

    Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

    What are Venlafaxine Hydrochloride Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • VENLAFAXINE HYDROCHLORIDE 75 mg/1 - A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT.

    Which are Venlafaxine Hydrochloride UNII Codes?

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

    Which are Venlafaxine Hydrochloride 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?

    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: 313581 - venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule
    • RxCUI: 313581 - 24 HR venlafaxine 150 MG Extended Release Oral Capsule
    • RxCUI: 313581 - venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule
    • RxCUI: 313583 - venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule
    • RxCUI: 313583 - 24 HR venlafaxine 37.5 MG Extended Release Oral Capsule

    Which are the Pharmacologic Classes for Venlafaxine Hydrochloride?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Norethindrone


    Norethindrone is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Norethindrone is also used to treat abnormal periods or bleeding and to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 3 months and who are not pregnant or experiencing menopause (change of life; the end of monthly menstrual periods). Norethindrone is in a class of medications called progestins. It works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones. Norethindrone is also used to prevent pregnancy. Norethindrone is sold under different brand names and is taken in smaller amounts when it used to prevent pregnancy. This monograph does not include information on the use of norethindrone to prevent pregnancy. If you are taking norethindrone to prevent pregnancy, read the monograph entitled Progestin-Only (norethindrone) Oral Contraceptives.
    [Learn More]


    Progestin-Only (norethindrone) Oral Contraceptives


    Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Progestin-only (norethindrone) oral contraceptives are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".