FD&C Blue No. 1 Aluminium Lake
Excipient (pharmacologically inactive substance)
What is FD&C Blue No. 1 Aluminium Lake?
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Blue No. 1 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. FD&C Blue No. 1 Aluminum Lake is approved for use in foods, drugs and cosmetics.
FD&C colors are the colors certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics. D&C notation specifies that the color can be used in drugs and cosmetics, but not food. According to the FDA, FD&C Blue No. 1 Aluminum Lake may be used safely as a color additive.
 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%3A184.108.40.206.27;idno=21;cc=ecfr#21:220.127.116.11.18.104.22.168
 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
Top Medications Containing FD&C Blue No. 1 Aluminium Lake
- Acyclovir 800 mg (Actavis)
- Acyclovir 200 mg (Actavis)
- Clonazepam 1 mg (Watson Pharmaceuticals)
- Diltia XT 240 mg (Andrx Pharmaceuticals)
- Diltia XT 180 mg (Andrx Pharmaceuticals)
- GLYBURIDE MICRONIZED 3 MG (Greenstone Limited)
- Hydromorphone Hydrochloride 4 mg (Ethex Corporation)
- Hydromorphone Hydrochloride 2 mg (Ethex Corporation)
- Panlor SS 712.8 mg / 60 mg / 32 mg (Pamlab LLC)
- Pentoxil 400 mg (Upsher-Smith Laboratories, Inc)
- Sertraline Hydrochloride 100 mg (Actavis)