The tariff classification of Levofloxacin, Venlafaxine Hydrochloride and Donepezil Hydrochloride, all in dosage form, from India

N150589 March 4, 2011 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9110; 3004.90.9135; 3004.90.9140 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Levofloxacin, Venlafaxine Hydrochloride and Donepezil Hydrochloride, all in dosage form, from India Dear Mr. Shah: In your letter dated February 15, 2011, you requested a tariff classification ruling. You state that the Levofloxacin will be imported in 35/325 mg tablets, the Venlafaxine Hydrochloride in 37.5/325 mg Extended Release tablets, and the Donepezil Hydrochloride in 5mg and 10 mg tablets. The first product, Levofloxacin, is a fluoroquinoline antibacterial. In oral form it is indicated in adults to treat a range of severe or life-threatening bacterial infections or bacterial infections that have failed to respond to other antibiotic classes. Levofloxacin is also marketed worldwide for oral and IV use, as well as used in ophthalmic solutions. Venlafaxine Hydrochloride is a structurally novel antidepressant indicated for the treatment of major depressive disorder. Donepezil Hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase. It is indicated for the treatment of mild to moderate dementia in patients with Alzheimer's disease. The applicable subheading for the Levofloxacin in 35/325 mg tablets 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. The applicable subheading for the Venlafaxine Hydrochloride in 37.5/325 mg Extended Release tablets will 3004.90.9135, 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: Antidepressants, tranquilizers, and other psychotherapeutic agents.” The rate of duty will be free. The applicable subheading for the Donepezil Hydrochloride in 5mg and 10mg tablets will be 3004.90.9140, 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: 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