https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm FDA DRUG LISTING FORM. Prescription drugs submitted for FDA approval after June 30, 2015 will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001 will be phased in gradually. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. All domestic firms which manufacture, prepare, propagate, compound, or process homeopathic drugs must register with FDA as drug establishment and list homeopathic drug products with US FDA. FDA Drug Listing & NDC Number Registration Services Drug Listing and NDC number assignment services. Agent services and Compliance Assistance to Food, Medical Devices, Cosmetics and Drug Industries. FDA Listing Inc. provides FDA drug establishment registration for domestic and foreign companies and can act as U.S. Parts of the data are published in the FDA National Drug Code Directory, FDA label repository, FDA drug establishment current registration site and NIH’s DailyMed. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Drug manufacturers are required to register their establishments with FDA annually to identify establishments for FDA inspection and to provide the agency with a list of drugs manufactured at the establishment. FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah, provided by ASHP as its exclusive authorized distributor, and used with permission. OTC drugs are defined as drugs that are safe and effective for use by individuals without requiring a prescription. See section 510 of the Federal Food, Drug, and Cosmetic Act and part 207 of Title 21 of the Code of Federal Regulations (CFR) for more information on the requirements for establishment registration and drug listing. Currently, there are over 300,000 marketed OTC drugs in the U.S. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market. See eDRLS instructions for information and instructions on the electronic submission process. FDA's Center for Drug Evaluation and Research (CDER) is evaluating and approving new drugs before they are sold in the US. Click for detailed instructions. Last updated on April 13, 2020. For four decades, the NDC Directory has been published by FDA, derived from information submitted to the agency as part of drug listing requirements under section 510 of the FD&C Act, 21 USC 360. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. (See 21 CFR part 207.) The Professional Drug Information database is a repository of drug information sourced directly from the FDA. FDA Drug Approval Process. The site is secure. FDA Listing.com Inc., referred as FDA Listing Inc., is a registered New York corporation providing FDA Registration and Listing, FDA U.S. To keep track, drug products are assigned a unique identifier, called the National Drug Code – or NDC – number. List of FDA Orphan Drugs GARD has information from the Food and Drug Administration (FDA) on treatments approved for rare diseases, known as orphan products/drugs. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Log-In Create Account. Registrants are required to submit initial listing information of all OTC drugs in commercial distribution at the time of FDA establishment registration. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. However, if you can avoid a possible drug interaction by selecting a different medication, that is always your best bet. If there is no change in drug information for all listed products, establishments can submit a blanket no change certification SPL to FDA, which will consider as all product listings are current and updated. The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. FDA Annual drug listing update and blanket submission. 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