NDC 0025-0166 Synarel

Nafarelin Acetate Spray, Metered Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0025-0166
Proprietary Name:
Synarel
Non-Proprietary Name: [1]
Nafarelin Acetate
Substance Name: [2]
Nafarelin Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route(s): [4]
  • Nasal - Administration to the nose; administered by way of the nose.
  • Labeler Name: [5]
    Pfizer Laboratories Div Pfizer Inc
    Labeler Code:
    0025
    FDA Application Number: [6]
    NDA019886
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-13-1990
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0025-0166-08

    Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 8 mL in 1 BOTTLE, SPRAY

    Product Details

    What is NDC 0025-0166?

    The NDC code 0025-0166 is assigned by the FDA to the product Synarel which is a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Synarel is nafarelin acetate. The product's dosage form is spray, metered and is administered via nasal form. The product is distributed in a single package with assigned NDC code 0025-0166-08 1 bottle, spray in 1 carton / 8 ml in 1 bottle, spray. 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 Synarel?

    Nafarelin is used in women to treat a condition in which the tissue that normally lines the inside of the uterus grows in the wrong place (endometriosis). This medication helps to decrease the abnormal tissue and also the symptoms of endometriosis (such as pelvic pain, painful menstrual cramps, and pain during/after sex). This medication is also used in children to treat a certain type of early puberty (central precocious puberty, gonadotropin-dependent). It helps to slow the bone aging and height growth rate so that both are near normal, and it helps to stop or reverse signs of early puberty (such as breast growth in girls, growth of sexual organs in boys). Nafarelin is similar to a natural hormone made by the body (gonadotropin-releasing hormone-GnRH). It works by decreasing the testosterone hormones in boys and estrogen hormones in women and girls.

    What are Synarel 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.
    • NAFARELIN ACETATE 2 mg/mL - A potent synthetic agonist of GONADOTROPIN-RELEASING HORMONE with 3-(2-naphthyl)-D-alanine substitution at residue 6. Nafarelin has been used in the treatments of central PRECOCIOUS PUBERTY and ENDOMETRIOSIS.

    Which are Synarel UNII Codes?

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

    Which are Synarel 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 Synarel?

    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: 1797878 - nafarelin 200 MCG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797878 - nafarelin 0.2 MG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797878 - nafarelin (as nafarelin acetate) 200 MCG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797880 - Synarel 200 MCG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797880 - nafarelin 0.2 MG/ACTUAT Metered Dose Nasal Spray [Synarel]

    Which are the Pharmacologic Classes for Synarel?

    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

    Nafarelin


    Nafarelin is a hormone used to treat symptoms of endometriosis such as pelvic pain, menstrual cramps, and painful intercourse. Nafarelin also is used to treat central precocious puberty (early puberty) in young boys and girls. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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.

    [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 ("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".