FD&C Blue No. 2

Excipient (pharmacologically inactive substance)

What is FD&C Blue No. 2?

FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Blue No. 2 (also known as indigotine, C16H10N2O2) is a colorant used for drug dosage forms such as tablets and capsules. It is also approved for use in foods and cosmetics.[1] [2]

[1] U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm

[2] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.2.31.35

Top Medications Containing FD&C Blue No. 2

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