Each active ingredient name is the preferred term of the UNII code submitted.
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. The following is the list of active ingredients in this product.
What are Butalbital, Acetaminophen And Caffeine Active Ingredients? The product's dosage form is tablet and is administered via oral form. 51862-540 - Butalbital, Acetaminophen And Caffeineīutalbital, Acetaminophen And Caffeine is a human prescription drug product labeled by Mayne Pharma.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"). This is the date when the listing record will expire if not updated or certified by the product labeler.Įxclude Flag What is the NDC Exclude Flag? Listing Expiration Date What is the Listing Expiration Date? This is the date that the labeler indicates was the start of its marketing of the drug product. Start Marketing Date What is the Start Marketing Date? The complete list of codes and translations can be found at under Structured Product Labeling Resources.ĪNDA - A product marketed under an approved Abbreviated New Drug Application. Currently, only final marketed product categories are included. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Marketing Category What is the Marketing Category? Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine. The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. For unapproved drugs, this field will be null.ĭEA Schedule What is the Drug Enforcement Administration (DEA) CIII Schedule? 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. This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. Name of Company corresponding to the labeler code segment of the Product NDC.įDA Application Number What is the FDA Application Number? Product Labeler Information What is the Labeler Name? Oral - Administration to or by way of the mouth.The translation of the route code submitted by the firm, indicating route of administration. Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.Īdministration Route(s) What are the Administration Route(s)? This data element matches the “Document Type” field of the Structured Product Listing. Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. Product Type What kind of product is this? The generic name usually includes the active ingredient(s) of the product. The non-proprietary name is sometimes called the generic name. Non-Proprietary Name What is the Non-Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. Proprietary Name What is the Proprietary Name?
0 kommentar(er)
