NDC 69315-282 Fenofibric Acid
Capsule, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
BLUE (C48333 - OPAQUE BLUE COLOR CAP, OPAQUE YELLOW COLOR BODY)
22 MM
168
Code Structure Chart
Product Details
What is NDC 69315-282?
What are the uses for Fenofibric Acid?
What are Fenofibric Acid Active Ingredients?
Which are Fenofibric Acid UNII Codes?
The UNII codes for the active ingredients in this product are:
- FENOFIBRIC ACID (UNII: BGF9MN2HU1)
- FENOFIBRIC ACID (UNII: BGF9MN2HU1) (Active Moiety)
Which are Fenofibric Acid 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:
- AMMONIA (UNII: 5138Q19F1X)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- GELATIN (UNII: 2G86QN327L)
- HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
- HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
- METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
- POVIDONE K30 (UNII: U725QWY32X)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
What is the NDC to RxNorm Crosswalk for Fenofibric Acid?
- RxCUI: 828373 - fenofibric acid 135 MG Delayed Release Oral Capsule
- RxCUI: 828379 - fenofibric acid 45 MG Delayed Release Oral Capsule
Which are the Pharmacologic Classes for Fenofibric Acid?
* Please review the disclaimer below.
Patient Education
Fenofibrate
Fenofibrate is used with a low-fat diet, exercise, and sometimes with other medications to reduce the amounts of fatty substances such as cholesterol and triglycerides in the blood and to increase the amount of HDL (high-density lipoprotein; a type of fatty substance that decreases the risk of heart disease) in the blood. Build-up of cholesterol and fats along the walls of the arteries (a process known as atherosclerosis) decreases the blood flow and, therefore, the oxygen supply to the heart, brain, and other parts of the body. This increases the risk of heart disease, angina (chest pain), strokes, and heart attacks. Although fenofibrate decreases the levels of fatty substances in the blood, it has not been shown to decrease the risk of heart attacks or strokes. Fenofibrate is in a class of medications called antilipemic agents. It works by speeding the natural processes that remove cholesterol from the body.
[Learn More]
* 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".