Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA’s Labeling Resources for Human Prescription Drugs

FDA’s Labeling Resources for Human Prescription Drugs

                        Prescribing Information Resources
          Patient Labeling Resources
          Carton and Container Labeling Resources
          Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
          Generic Drugs - Specific Labeling Resources
          Biological Products - Specific Labeling Resources
          Frequently Asked Questions about Labeling for Prescription Medicines
          Prescription Drug Labeling Contact Information Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Laws, Acts, and Rules
          FDA’s Labeling Resources for Human Prescription Drugs
          Prescription Drug Labeling Contact InformationFDA’s Labeling Resources for Human Prescription Drugs Prescription Drug Labeling Contact Information
  
  	
    Share
    Post
    Linkedin

    Email
    PrintFor specific application or supplement questions, please contact

Office of New Drugs prescription drug review division for NDAs/BLAs regulated in Center for Drug Evaluation and Research (CDER)
	Office of Generic Drugs for ANDAs regulated in CDER
	Center for Biologics Evaluation and Research (CBER) for ANDAs, BLAs, or NDAs regulated in CBERFor general questions about the Prescribing Information or this website contact the Labeling Policy Team in CDER.

*For the purposes of these webpages, references to drugs include drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act and biological products licensed under section 351 of the Public Health Service Act that are regulated as drugs.  Not every resource on this website will be applicable to every prescription drug.

                                                                                  Content current as of:
      06/03/2022
              
              
Regulated Product(s)
		 DrugsFDA’s Labeling Resources for Human Prescription Drugs

          
                        Prescribing Information Resources
          Patient Labeling Resources
          Carton and Container Labeling Resources
          Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
          Generic Drugs - Specific Labeling Resources
          Biological Products - Specific Labeling Resources
          Frequently Asked Questions about Labeling for Prescription Medicines
          Prescription Drug Labeling Contact Information
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop