The tariff classification of Tacrolimus Capsules, Tacrolimus Injection and Donepezil Hydrochloride Tablets, imported in dosage form, from India

N238465 March 6, 2013 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115; 3004.90.9140 Mr. Pradeep Shah Zydus Pharmaceuticals (USA) Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Tacrolimus Capsules, Tacrolimus Injection and Donepezil Hydrochloride Tablets, imported in dosage form, from India Dear Mr. Shah: In your letter dated February 5, 2013, you requested a tariff classification ruling. Tacrolimus Capsules and Tacrolimus Injection, are medicinal preparations containing Tacrolimus, an immunosuppressant, as the active ingredient. Both products are used in conjunction with other medications to prevent the body from rejecting transplanted organs. According to your letter, it will be imported in capsule form (.5 mg, 1 mg and 5 mg) and in 5 mg/mL injections. Donepezil Hydrochloride Tablets, imported in 23 mg tablet form, 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 Tacrolimus Capsules and Tacrolimus Injection in dosage form will be 3004.90.9115, 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: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free. The applicable subheading for the Donepezil Hydrochloride Tablets in dosage form 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 Judy Lee at (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division