The tariff classification of Amantadine Hydrochloride capsules and Acamprosate Calcium delayed release capsules in dosage form, from Spain and India, respectively

N276754 July 8, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9110; 3004.90.9140 Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Amantadine Hydrochloride capsules and Acamprosate Calcium delayed release capsules in dosage form, from Spain and India, respectively Dear Mr. Shah: In your letter dated June 17, 2016, you requested a tariff classification ruling. Amantadine Hydrochloride, imported in 100 mg capsules, is an antiviral that is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. In your letter, you indicated that the active ingredient (Amantadine Hydrochloride) is sourced from Spain but the finished product is manufactured in India. Acamprosate Calcium, imported in 333 mg delayed release tablets, is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence. The applicable subheading for the Amantadine Hydrochloride capsules in dosage form will be 3004.90.9110, 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: Anti-infective medicaments: Other.” The rate of duty will be free. The applicable subheading for the Acamprosate Calcium delayed release tablets in dosage form will be 3004.90.9140, 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: Medicaments primarily affecting the central nervous system: 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