Region Breakdown

US Drug Products

Learn how DrugBank sources & enhances FDA-approved drug information for integration in your software.

How do drugs get approved and regulated in the US?

Within the United States, the Food and Drug Administration (FDA) reviews and approves applications for new drugs, generics, OTCs, and biological products.

Specifically, two FDA divisions, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), are responsible for carrying out the process and monitoring drug safety data once drugs are available on the market.

The challenge with existing and open source databases

There are a variety of databases available from the FDA and the National Library of Medicine (NLM) on drug products sold in the US. These include DailyMed, National Drug Code (NDC) Directory, Drugs@FDA Database, and Orange Book. While these exist for different reasons with data unique to each source, they also contain overlapping information. Most challenging, they can be complex and unsuitable for immediate integration into applications.

DrugBank’s US Regional Data Solution

DrugBank’s US regional drug product information pulls data from all FDA sources. Our team of medical experts including doctors, pharmacologists and pharmacists—armed with AI tools—parse, verify, annotate, and structure the data for immediate and easy use. Once processed, the data is then imported into our database and connected with DrugBank’s extensive datasets, ontologies, and proprietary authored content.

DrugBank imports and structures FDA-approved product information such as:

  • Product Name
  • Ingredients
  • NDC Codes
  • FDA Application Numbers (NDA, ANDA, BLA)
  • Strengths
  • Routes
  • Forms

Easily search and integrate with a single API

DrugBank’s US drug products information can be easily queried and accessed through DrugBank’s Clinical API. This means faster and easier integration into your software to help healthcare professionals and patients make better health decisions. Additionally, DrugBank’s US Drug Labels module imports and simplifies product label information from DailyMed that can be readily displayed in your application.

Learn more about our Clinical API

Learn more about our US Drug Labels module

Integrate our US regional data today!