NDC 65862-928 Sumatriptan And Naproxen Sodium
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 65862 - Aurobindo Pharma Limited
- 65862-928 - Sumatriptan And Naproxen Sodium
Product Characteristics
Product Packages
NDC Code 65862-928-36
Package Description: 9 TABLET, FILM COATED in 1 BOTTLE
Price per Unit: $20.31889 per EA
Product Details
What is NDC 65862-928?
What are the uses for Sumatriptan And Naproxen Sodium?
What are Sumatriptan And Naproxen Sodium Active Ingredients?
- 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:
- SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989)
- SUMATRIPTAN (UNII: 8R78F6L9VO) (Active Moiety)
- NAPROXEN SODIUM (UNII: 9TN87S3A3C)
- NAPROXEN (UNII: 57Y76R9ATQ) (Active Moiety)
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:
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- CROSPOVIDONE (UNII: 2S7830E561)
- DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- MALTODEXTRIN (UNII: 7CVR7L4A2D)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POVIDONE K90 (UNII: RDH86HJV5Z)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
- SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Sumatriptan And Naproxen Sodium?
- 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?
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Serotonin 1b Receptor Agonists - [MoA] (Mechanism of Action)
- Serotonin 1d Receptor Agonists - [MoA] (Mechanism of Action)
- Serotonin-1b and Serotonin-1d Receptor Agonist - [EPC] (Established Pharmacologic Class)
* 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.
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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.
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* Please review the disclaimer below.
[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".