The tariff classification of Desmopressin Acetate, Letrozole and Clopidogrel, all in dosage form, from India

N150591 March 4, 2011 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.39.0050; 3004.90.9115; 3004.90.9120 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Desmopressin Acetate, Letrozole and Clopidogrel, all in dosage form, from India Dear Mr. Shah: In your letter dated February 16, 2011, you requested a tariff classification ruling. You state that the Desmopressin Acetate will be imported in a dosage form nasal spray, the Letrozole in 2.5mg tablets, and the Clopidogrel in 75mg and 300mg tablets. Desmopressin Acetate is a vasopressin (a posterior pituitary polypeptide hormone) analog, which is used as an antidiuretic drug. Letrozole, is a non-steroidal aromatase inhibitor. It is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. It is indicated for the reduction of arterothrombotic events for patients with recent myocardial infarction, recent stroke, established peripheral arterial disease, and acute coronary syndrome. The applicable subheading for the Desmopressin Acetate nasal spray 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Other: Other.” The rate of duty will be free. The applicable subheading for the Letrozole 2.5mg tablets will 3004.90.9115, 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. The applicable subheading for the Clopidogrel 75mg and 300mg tablets will be 3004.90.9120, 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: Cardiovascular 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