The tariff classification of Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets, imported in dosage forms, from India

N232957 September 21, 2012 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9185 Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets, imported in dosage forms, from India Dear Mr. Shah: In your letter dated August 30, 2012, you requested a tariff classification ruling. The subject products, Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets, are medicinal preparations containing Montelukast, a leukotriene receptor antagonist (LTRA), as the active ingredient. Both products are indicated for the treatment of asthma and relieve symptoms of seasonal allergies. They will be imported in dosage form in 4 mg, 5 mg and 10 mg tablets. The applicable subheading for the Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets in dosage form will be 3004.90.9185, 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) Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: 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