The tariff classification of Lubiprostone Capsules and Zituvio (Sitagliptin) Tablets in dosage form, from India

N328649 November 1, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.39.0050; 3004.90.9291 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Lubiprostone Capsules and Zituvio (Sitagliptin) Tablets in dosage form, from India Dear Mr. Shah: In your letter dated October 6, 2022, you requested a tariff classification ruling. Lubiprostone, imported in 8 mcg and 24 mcg capsules, is a prostaglandin E1 derivative. It is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Zituvio (Sitagliptin), imported in 25 mg, 50 mg, and 100 mg tablets, is an antidiabetic drug of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The applicable subheading for the Lubiprostone Capsules in dosage form will be 3004.39.0050, 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, containing hormones or other products of heading 2937: Other: Other.” The rate of duty will be free. The applicable subheading for the Zituvio (Sitagliptin) Tablets in dosage form will be 3004.90.9291, 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: 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division