Skip to Content

FD&C Blue No. 2

Excipient (pharmacologically inactive substance)

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.

[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.;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.;idno=21;cc=ecfr#21:

Top Medications with this excipient