The tariff classification of Ondansetron Orally Disintegrating Tablets in dosage form, from India

N293526 February 5, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9260 Ms. Paulina Radaczynska BluePoint Laboratories Eastgate Business Park 8 Eastgate Avenue Little Island, Cork Ireland RE: The tariff classification of Ondansetron Orally Disintegrating Tablets in dosage form, from India Dear Ms. Radaczynska: In your letter dated January 19, 2018, you requested a tariff classification ruling. The subject product, Ondansetron Orally Disintegrating Tablets, imported in 4 mg and 8 mg tablets, is a medicinal preparation containing Ondansetron, a serotonin 5-HT3 receptor antagonist, as the active ingredient. It is indicated for the prevention of nausea and vomiting associated with cytotoxic chemotherapy drugs, radiation therapy and surgery. The applicable subheading for the Ondansetron Orally Disintegrating Tablets will be 3004.90.9260, 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 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 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