The tariff classification of Olmesartan Medoxomil Tablets and Spironolactone Tablets in dosage form, from India and China, respectively

N276537 July 7, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.39.0050; 3004.90.9120 Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Olmesartan Medoxomil Tablets and Spironolactone Tablets in dosage form, from India and China, respectively Dear Mr. Shah: In your letter dated June 10, 2016, you requested a tariff classification ruling. Olmesartan Medoxomil Tablets, imported in 5 mg, 20 mg and 40 mg, is indicated for the treatment of hypertension to lower blood pressure. Spironolactone Tablets, imported in 25 mg, 50 mg and 100 mg, is indicated for the management of hyperaldosteronism. In your letter, you indicated that the active ingredient (Spironolactone) is sourced from China but the finished product is manufactured in India. The applicable subheading for the Olmesartan Medoxomil Tablets in dosage form will be 3004.90.9120, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Cardiovascular medicaments.” The rate of duty will be free. The applicable subheading for the Spironolactone Tablets in dosage form will be 3004.39.0050, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms of packings for retail use: Containing hormones or other products of 2937 but not containing antibiotics: Other: Other.” 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 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division