Clinical Pharmacology includes information regarding US marketed drug products, including prescription, over-the-counter (OTC), nutritional, and herbal products. All drug product information is obtained from product labeling as provided by the manufacturer/marketer. All drug product information is presented in a standardized format to provide the following information:
Orange Book Therapeutic Equivalence (TE) Rating (where applicable)
Product Identifier (NDC, UPC)
Drug Product and Package Images
To ensure the most up to date drug product information, the Clinical Pharmacology Drug Product team updates information in a "real time" format. This allows for tremendous flexibility as well as the ability to be responsive to the latest drug product approvals, discontinuations, and changes. Drug product updates are based on information obtained directly from the manufacturer and/or marketer.
The product name includes the name of the product as described in the product labeling as well as the strength(s) and dosage form. The marketer is also listed for each product. The marketer is the company responsible for marketing the product; however, this may not be the manufacturer (i.e., the company that made the product). Additionally, the marketer may or may not be the company that holds the NDA or ANDA.
When the Drug Product team receives information from the manufacturer that a product is no longer shipping, that product is marked as "off-market". The product may still be available in a wholesaler inventory or in pharmacies. Unless a product is discontinued and recalled for safety reasons, a product may continue to be available on the market until the final expiration date of the last lot of the product. For products where detailed product information cannot be verified through the manufacturer, the product is marked as off-market.
The example below shows a number of results from the Find Drugs By Classification listing that shows a number of drugs off the market.
For drug products that include Medication Guides
or REMS (Risk Evaluation Mitigation Strategies),
the drug product detail displays a REMS Summary Alert icon 
or MedGuides Alert icon 
to the right of the Product Name. Click on the icon to open a popup window
containing links to specific REMS
or MedGuide
information.
This field designates if the product requires a prescription (Rx) to obtain it or if it is available without a prescription or "over-the-counter" (OTC). Just because a product requires a prescription, does not mean the product is approved by the FDA; only products with a NDA or ANDA are reviewed and approved by the FDA. OTC products include drugs, vitamins, and other nutritional or natural supplements.
(http://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm)
Clinical Pharmacology lists, where appropriate, the federal controlled substance schedule for a product. While individual states may not designate schedule lower than the one assigned at the federal level, states may assign more restrictive status; consult your state’s controlled substance regulations for more information. (See Important Terms from the Table of Contents for definitions of Federal Schedules of Controlled Substances.)
(http://www.fda.gov/cder/ob/default.htm)
Clinical Pharmacology reports therapeutic equivalence ratings as designated within the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and contains therapeutic equivalence evaluations for approved multi-source products. Distributors and re-packagers of an application holder's drug product are considered to have the same code as the application holder. (See Important Terms from the Table of Contents for therapeutic equivalence code abbreviations.)
In order to provide further clarification, Clinical Pharmacology indicates where Orange Book Therapeutic Equivalence (TE) codes do not apply. Products listed in the Orange Book that are not multi-source (i.e., no FDA-approved generic equivalents) have the TE rating of "NR" (Not Rated). Products that are not reviewed by the FDA such as those marketed before 1938, vitamins, and nutritional supplements will have a TE code of "NA" (Not Applicable). In addition, all products designated as "off market" include the TE code assigned, if applicable, when the product was placed off-market.
From the product detail section of How Supplied, an information box opens from the Orange Book Codes link. Examples of the link and the popup display below.
Clinical Pharmacology drug product includes FDA pregnancy risk ratings as applied in the product labeling. To provide, additional information, these ratings are reported per trimester. However, this may not provide the depth of information required; therefore, Clinical Pharmacology includes additional information within the Contraindication/Precaution section of the monograph. Products that do not have an FDA Pregnancy Risk Rating reported in the product labeling are marked as "Pregnancy Category Not Available". (See Important Terms from the Table of Contents for FDA Pregnancy Risk Ratings)
From the product detail section of How Supplied, an information box opens from the FDA Pregnancy Risk Ratings link. Examples of the link and the popup display below.
Clinical Pharmacology utilizes a proprietary therapeutic classification system that considers pharmacologic properties and therapeutic use of drug products. This therapeutic classification system is based on established scientific or factual pharmacologic and therapeutic classifications of these drugs, but does not necessarily a class system based on intent for marketing. The classes closely follow those of the WHO ATC (Anatomic and Therapeutic classification) and CAS registry. Therapeutic US marketed drug products listed in Clinical Pharmacology are included in this classification system.
Information regarding the appropriate and recommended storage of a product is also provided within the detailed product information. This information is based on the product labeling information.
Individual packages of a product are described separately within the Clinical Pharmacology detailed drug product information. For each package, a unique identifier is given (NDC, UPC), a package description that includes formulation (ingredient(s) and strength(s)), package size, and other components (i.e., diluents, syringes, alcohol swabs, etc). Also included for each package is a description of each drug component (e.g., color, shape, imprint) and a listing of the inactive ingredients. This description also includes product and/or package images when available.
In some cases, manufacturers change the appearance of drug products without change the product identifier (i.e., NDC or UPC). When information is available, the product information within Clinical Pharmacology includes a description of the previous appearance of the product. For oral solids, the imprint/markings, color, shape, and dosage form is searchable from the Drug IDentifier feature.
The example below shows a prior version of a Crestor product.
