The tariff classification of Bromocriptine Mesylate Tablets (2.5 mg) and Capsules (5 mg), Bicalutamide Tablets (50 mg), and Dipyridamole Tablets (25mg, 50 mg, 75 mg) from India

N022256 January 25, 2008 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.40.0040; 3004.90.9115; 3004.90.9120 Mr. Pradeep Shah Zydus Pharmaceuticals (USA) Inc. 210 Carnegie Center, Suite 103 Princeton, NJ 08540 RE: The tariff classification of Bromocriptine Mesylate Tablets (2.5 mg) and Capsules (5 mg), Bicalutamide Tablets (50 mg), and Dipyridamole Tablets (25mg, 50 mg, 75 mg) from India Dear Mr. Shah: In your letter dated January 15, 2008, you requested a tariff classification ruling. Bromocriptine Mesylate in tablet and capsule forms is a medicinal preparation, in dosage form, based on a semisynthetic ergot alkaloid derivative. Bromocriptine Mesylate is indicated for the treatment of hyperprolactinemia-associated dysfunctions, acromegaly and Parkinsonism. Bicalutamide in tablet form is a medicinal preparation, in dosage form, based on a non-steroidal anti-androgenic. Bicalutamide is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analogue for the treatment of Stage D2 metastatic carcinoma of the prostate. Dipyridamole in tablet form is a medicinal preparation, in dosage form, based on a vasodilator. It is indicated for use in combination with warfarin for postoperative primary prophylaxis of thromboemboli in patients with prosthetic heart valves. The applicable subheading for the Bromocriptine Mesylate 2.5 mg tablets and 5 mg capsules will be 3004.40.0040 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 alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics: Other: Medicaments primarily affecting the central nervous system: Other.” The rate of duty will be free. The applicable subheading for the Bicalutamide 50 mg tablets will be 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 Dipyridamole 25mg, 50 mg and 75 mg 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 (including those in the form of transdermal administration systems) 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