The tariff classification of Namenda® Extended Release imported in dosage form, from Ireland

N226796 August 17, 2012 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9140 Mr. Mark Huntebrinker Forest Pharmaceuticals, Inc. 13600 Shoreline Drive Earth City, MO 63045 RE: The tariff classification of Namenda® Extended Release imported in dosage form, from Ireland Dear Mr. Huntebrinker: In your letter dated July 18, 2012, you requested a tariff classification ruling. The subject product, Namenda® Extended Release, imported in 7 mg, 14 mg, 21 mg, and 28 mg capsule form is a medicinal preparation containing, Memantine Hydrochloride, an orally active (NMDA) receptor antagonist, as the active ingredient. It is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.The applicable subheading for the Namenda® Extended Release, imported in dosage form 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. 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 ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). 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. 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