NDC 66869-564 Seglentis
Celecoxib And Tramadol Hydrochloride Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 66869 - Kowa Pharmaceuticals America, Inc.
- 66869-564 - Seglentis
Product Characteristics
Product Packages
NDC Code 66869-564-30
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET in 1 BOTTLE, PLASTIC
NDC Code 66869-564-35
Package Description: 35 TABLET in 1 BOTTLE, PLASTIC
Price per Unit: $4.35147 per EA
NDC Code 66869-564-90
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 90 TABLET in 1 BOTTLE, PLASTIC
Price per Unit: $4.35147 per EA
Product Details
What is NDC 66869-564?
What are the uses for Seglentis?
What are Seglentis Active Ingredients?
- CELECOXIB 56 mg/1 - A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.
- TRAMADOL HYDROCHLORIDE 44 mg/1 - A narcotic analgesic proposed for severe pain. It may be habituating.
Which are Seglentis UNII Codes?
The UNII codes for the active ingredients in this product are:
- CELECOXIB (UNII: JCX84Q7J1L)
- CELECOXIB (UNII: JCX84Q7J1L) (Active Moiety)
- TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK)
- TRAMADOL (UNII: 39J1LGJ30J) (Active Moiety)
Which are the Pharmacologic Classes for Seglentis?
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Patient Education
Celecoxib
Celecoxib 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), and ankylosing spondylitis (arthritis that mainly affects the spine). Celecoxib is also used to treat juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Celecoxib is also used to treat painful menstrual periods and to relieve other types of short-term pain including pain caused by injuries, surgery and other medical or dental procedures, or medical conditions that last for a limited time. Celecoxib is in a class of NSAIDs called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation.
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Tramadol
Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
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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.
[7] What is the Drug Enforcement Administration (DEA) CIV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[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".