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  4. NDC Product Code: 54436-350 Nocdurna

NDC 54436-350 Nocdurna

Desmopressin Acetate Tablet Sublingual - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54436-350?
  5. Nocdurna 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:
54436-350
Proprietary Name:
Nocdurna
Non-Proprietary Name: [1]
Desmopressin Acetate
Substance Name: [2]
Desmopressin Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
    • Labeler Name: [5]
    Antares Pharma, Inc.
    Labeler Code:
    54436
    Product Label ID:
    cf51914a-55df-4b4a-8ea8-c7af257c1d59
    FDA Application Number: [6]
    NDA022517
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-06-2021
    End Marketing Date: [10]
    05-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    14 MM
    Imprint(s):
    25
    50
    Score:
    1

    Product Packages

    NDC Code 54436-350-30

    Package Description: 3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (54436-350-10)

    Product Details

    What is NDC 54436-350?

    The NDC code 54436-350 is assigned by the FDA to the product Nocdurna which is a human prescription drug product labeled by Antares Pharma, Inc.. The generic name of Nocdurna is desmopressin acetate. The product's dosage form is tablet and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 54436-350-30 3 blister pack in 1 carton / 10 tablet in 1 blister pack (54436-350-10). 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 Nocdurna?

    Desmopressin is used to control the amount of urine your kidneys make. Normally, the amount of urine you make is controlled by a certain substance in the body called vasopressin. In people who have "water diabetes" (diabetes insipidus) or certain kinds of head injury or brain surgery, the body does not make enough vasopressin. Desmopressin is a man-made form of vasopressin and is used to replace a low level of vasopressin. This medication helps to control increased thirst and too much urination due to these conditions, and helps prevent dehydration. Desmopressin is also used by adults who wake up 2 or more times during the night to urinate due to a condition called nocturnal polyuria. It helps reduce how often you wake up at night to urinate. Desmopressin is also used to treat children who wet the bed at night. It helps decrease the number of times the child urinates and wets the bed.

    What are Nocdurna 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.
    • DESMOPRESSIN ACETATE 55.3 ug/1 - A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.

    Which are Nocdurna UNII Codes?

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

    Which are Nocdurna 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 Nocdurna?

    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:

    Which are the Pharmacologic Classes for Nocdurna?

    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

    Desmopressin


    Desmopressin is used to control the symptoms of a certain type of diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine). Desmopressin is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery. Desmopressin is also used to control bed-wetting. Desmopressin is in a class of medications called hormones. It works by replacing vasopressin, a hormone that is normally produced in the body to help balance the amount of water and salt.
    [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".