The tariff classification of Ezetimibe/Simvastatin Tablets in dosage form, from India

N301331 November 20, 2018 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9220 Ms. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork, T12 XN72 Ireland RE: The tariff classification of Ezetimibe/Simvastatin Tablets in dosage form, from India Dear Ms. Keeler: In your letter dated October 23, 2018, you requested a tariff classification ruling. Ezetimibe/Simvastatin Tablets is a combination medication containing ezetimibe (a selective inhibitor of intestinal cholesterol and related phytosterol absorption) and simvastatin (an HMG-CoA reductase inhibitor), as the active ingredients. It is indicated as adjunctive therapy to diet to reduce elevated total-cholesterol, LDL-cholesterol, Apo B, TG, and non-HDL-cholesterol, and to increase HDL-cholesterol in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. It is also used to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. Ezetimibe/Simvastatin Tablets will be imported in dosages of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. The applicable subheading for the Ezetimibe/Simvastatin Tablets in dosage form will be 3004.90.9220, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Cardiovascular medicaments.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division