Synthetic Ferric Oxide Black
Excipient (pharmacologically inactive substance)
What is Synthetic Ferric Oxide Black?
FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. Ferric oxide black (Fe3O4), also known as iron (III) oxide, is a coloring agent for tablets and capsules and is used in the pharmaceutical industry. Iron oxides are also commonly used in the cosmetics industry. Iron oxides for use in pharmaceutical manufacturing may also be synthetic.[1][2]
[1] Dave RH. Overview of pharmaceutical excipients used in tablets and capsules. Drug Topics (online). Advanstar. 10/24/2008 http://drugtopics.modernmedicine.com/drugtopics/Top+News/Overview-of-pharmaceutical-excipients-used-in-tabl/ArticleStandard/Article/detail/561047. Accessed 08/19/2011
[2] 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 Synthetic Ferric Oxide Black
- Diclofenac Sodium Delayed Release 50 mg (Actavis)
- Diltiazem Hydrochloride Extended-Release (SR) 120 mg (Mylan Pharmaceuticals Inc.)
- Fluoxetine Hydrochloride 20 mg (Mallinckrodt Pharmaceuticals)
- Fluoxetine Hydrochloride 10 mg (Mallinckrodt Pharmaceuticals)
- Gabapentin 800 mg (Actavis)
- Gabapentin 300 mg (Actavis)
- Hydrochlorothiazide 12.5 mg (Mylan Pharmaceuticals Inc.)
- Hydrochlorothiazide and Triamterene 25 mg / 37.5 mg (Sandoz Pharmaceuticals Inc.)
- Hydrochlorothiazide and Triamterene 25 mg / 37.5 mg (Mylan Pharmaceuticals Inc.)
- HydrOXYzine Pamoate 25 mg (Watson Pharmaceuticals)
- Hydroxyzine Pamoate 50 mg (Watson Pharmaceuticals)
- Nicardipine Hydrochloride 30 mg (Mylan Pharmaceuticals Inc.)
- Nicardipine Hydrochloride 20 mg (Mylan Pharmaceuticals Inc.)
- Omeprazole Delayed Release 20 mg (Dr. Reddy’s Laboratories Inc.)
- Omeprazole Delayed Release 40 mg (Dr. Reddy’s Laboratories Inc.)
- Palladone 32 mg (Purdue Pharma LP)
- Propranolol Hydrochloride Extended Release 60 mg (Actavis)
- Propranolol Hydrochloride Extended Release 80 mg (Actavis)
- Propranolol Hydrochloride Extended Release 120 mg (Actavis)
- Tetracycline Hydrochloride 250 mg (Barr Laboratories, Inc.)
