NDC 47335-410 Sumatriptan And Naproxen Sodium

Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
47335-410
Proprietary Name:
Sumatriptan And Naproxen Sodium
Non-Proprietary Name: [1]
Sumatriptan And Naproxen Sodium
Substance Name: [2]
Naproxen Sodium; Sumatriptan Succinate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Sun Pharmaceutical Industries, Inc.
    Labeler Code:
    47335
    FDA Application Number: [6]
    ANDA202803
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-20-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    OVAL (C48345)
    Size(s):
    21 MM
    Imprint(s):
    410
    Score:
    1

    Product Packages

    NDC Code 47335-410-22

    Package Description: 9 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $18.33444 per EA

    NDC Code 47335-410-83

    Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 47335-410-88

    Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 47335-410?

    The NDC code 47335-410 is assigned by the FDA to the product Sumatriptan And Naproxen Sodium which is a human prescription drug product labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 47335-410-22 9 tablet, film coated in 1 bottle , 47335-410-83 30 tablet, film coated in 1 bottle , 47335-410-88 100 tablet, film coated 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 Sumatriptan And Naproxen Sodium?

    Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use:Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets  are administered to treat any subsequent attacks.Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks.Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.Pediatric use information for patients ages 12 to 17 years is approved for Pernix Ireland Ltd.’s TREXIMET® (sumatriptan and naproxen sodium) Tablets. However, due to Pernix Ireland Ltd.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

    What are Sumatriptan And Naproxen Sodium 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.
    • NAPROXEN SODIUM 500 mg/1 - An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
    • SUMATRIPTAN SUCCINATE 85 mg/1 - A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.

    Which are Sumatriptan And Naproxen Sodium UNII Codes?

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

    Which are Sumatriptan And Naproxen Sodium 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 Sumatriptan And Naproxen Sodium?

    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: 849450 - SUMAtriptan 85 MG / naproxen sodium 500 MG Oral Tablet
    • RxCUI: 849450 - naproxen sodium 500 MG / sumatriptan 85 MG Oral Tablet
    • RxCUI: 849450 - naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral Tablet

    Which are the Pharmacologic Classes for Sumatriptan And Naproxen Sodium?

    * Please review the disclaimer below.

    Patient Education

    Naproxen


    Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
    [Learn More]


    Sumatriptan


    Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea or sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have.
    [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".