The tariff classification of Aripiprazole Orally Disintegrating Tablets in dosage form, from India

N263789 April 30, 2015 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9135 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Aripiprazole Orally Disintegrating Tablets in dosage form, from India Dear Mr. Shah: In your letter dated April 8, 2015 you requested a tariff classification ruling. The subject product, Aripiprazole Orally Disintegrating Tablets, imported in 10 mg, 15 mg, 20 mg and 30 mg tablets, is a medicinal preparation containing Aripiprazole, a psychotropic drug as the active ingredient. It is indicated for the treatment of schizophrenia and the acute treatment of manic and mixed episodes associated with bipolar disorder. The applicable subheading for the Aripiprazole Orally Disintegrating Tablets in dosage form will be 3004.90.9135, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments (excluding goods of heading 3002, 3005 or 3006) 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: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division