The tariff classification of Divalproex Sodium DR Tablets, Divalproex Sodium ER Tablets, Divalproex Sodium Sprinkle Capsules and Hydroxychloroquine Sulfate Tablets in dosage form, from India

N017941 October 15, 2007 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9130; 3004.90.9110 Mr. Pradeep Shah Zydus Pharmaceuticals(USA) Inc. 210 Carnegie Center, Suite 103, First Floor Princeton, NJ 08540 RE: The tariff classification of Divalproex Sodium DR Tablets, Divalproex Sodium ER Tablets, Divalproex Sodium Sprinkle Capsules and Hydroxychloroquine Sulfate Tablets in dosage form, from India Dear Mr. Shah: In your letter dated September 21, 2007, you requested a tariff classification ruling. The following three products, Divalproex Sodium DR Tablets in 125 mg, 250 mg and 500 mg, ER Tablets in 250 mg and 500 mg and Divalproex Sodium Sprinkle Capsules in 125 mg all contain the active ingredient Divalproex Sodium. Divalproex Sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. It is indicated for treatments ranging from bipolar disorders to seizures to migraine headaches. The fourth product, Hydroxychloroquine Sulfate Tablets in 200mg is an antimalarial agent. It is indicated primarily for the treatment of malaria. The applicable subheading for the Divalproex Sodium DR Tablets, ER Tablets and Sprinkle Capsules 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 Hydroxchloroquine Sodium DR Tablets 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. 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