3/17/2023 0 Comments Belbuca 300 mcg![]() ![]() 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? Buccal - Administration directed toward the cheek, generally from within the mouth.The translation of the route code submitted by the firm, indicating route of administration. This data element matches the “Document Type” field of the Structured Product Listing.įilm, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.Īdministration Route(s) What are the Administration Route(s)? 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? ![]()
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