The tariff classification of Ramelteon Tablets and Mesalamine Rectal Suppositories in dosage form, from India

N303649 April 17, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9230; 3004.90.9260 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Ramelteon Tablets and Mesalamine Rectal Suppositories in dosage form, from India Dear Mr. Shah In your letter dated March 26, 2019, you requested a tariff classification ruling. Ramelteon, imported in 8 mg tablets, is an orally active hypnotic agent indicated for the treatment of insomnia characterized by difficulty with sleep onset. Mesalamine, imported in 1000 mg suppositories for rectal use, is an anti-inflammatory drug indicated for the treatment of ulcerative proctitis. The applicable subheading for the Ramelteon Tablets in dosage form will be 3004.90.9230, 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: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” The rate of duty will be free. The applicable subheading for the Mesalamine Rectal Suppositories in dosage form will be 3004.90.9260, 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 digestive 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 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division