The tariff classification of Donepezil tablets, Venlafaxine ER capsules, and Levofloxacin tablets from India

N159795 April 22, 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 Donepezil tablets, Venlafaxine ER capsules, and Levofloxacin tablets from India Dear Mr. Shah: In your letter dated April 4, 2011, you requested a tariff classification ruling. The first product, Donepezil tablets imported in 5mg and 10mg dosage sizes, contains Donepezil Hydrochloride as the active ingredient. It 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 second product, Venlafaxine ER capsules imported in 37.5mg, 75mg and 150mg dosage sizes, contains Venlafaxine Hydrochloride as the active ingredient. It is a structurally novel antidepressant indicated for the treatment of major depressive disorder. The last product, Levofloxacin tablets imported in 250mg, 500mg and 750mg sizes, contains Levofloxacin as the active ingredient. It is a fluoroquinoline antibacterial. It is indicated for the treatment of many different types of bacterial infections. The applicable subheading for the Donepezil Hydrochloride in 5mg and 10 mg tablets will be 3004.90.9140, 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: Other.” The rate of duty will be free. The applicable subheading for the Venlafaxine Hydrochloride ER in 37.5mg, 75mg and 150mg capsules will be 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 Levofloxacin in 250mg, 500mg and 750mg 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 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