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FD&C Blue No. 2

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Aug 18, 2018.

What is it?

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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