The tariff classification of Lamotrigine Tablets, Lamotrigine Chewable Dispersible Tablets, Mycophenolate Mofetil Capsules and Tablets in dosage form, from India

N041656 October 28, 2008 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9130; 3004.90.9115 Mr. Pradeep Shah Zydus Pharmaceutical (USA) Inc. 210 Carniege Center, Suite 103 Princeton, NJ 08540 RE: The tariff classification of Lamotrigine Tablets, Lamotrigine Chewable Dispersible Tablets, Mycophenolate Mofetil Capsules and Tablets in dosage form, from India Dear Mr. Shah: In your letter dated October 9, 2008, you requested a tariff classification ruling. The first two products, Lamotrigine Tablets ranging from 25mg to 250mg and Lamotrigine Chewable Dispersible Tablets in 2mg, 5mg and 25mg, are anticonvulsant drugs indicated for the treatment of epilepsy for partial seizures and seizures associated with Lennox-Gastaut syndrome. The last two products, Mycophenolate Mofetil Capsules in 250mg and Mycophenolate Mofetil Tablets in 500mg are immunosuppressant drugs. They are indicated for the prevention of organ rejection in patients receiving renal, cardiac or hepatic transplants. The applicable subheading for the Lamotrigine Tablets and Chewable Dispersible Tablets in dosage form will be 3004.90.9130, 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 Mycophenolate Mofetil Capsules and Tablets in dosage form will be 3004.90.9115, , 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: Antineoplastic and immunosuppressive medicaments." 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 http://www.usitc.gov/tata/hts/. 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division