The tariff classification of Etodolac Tablets, Calcitriol Capsules, and Azelastine Hydrochloride Nasal Spray imported in dosage form, from India

N093284 February 16, 2010 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9128; 3004.50.5020; 3004.90.9180 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 210 Carnegie Center, Suite 103 Princeton, NJ 08540 RE: The tariff classification of Etodolac Tablets, Calcitriol Capsules, and Azelastine Hydrochloride Nasal Spray imported in dosage form, from India Dear Mr. Shah: In your letter dated January 25, 2010, you requested a tariff classification ruling. The first product, Etodolac, imported in 400 mg, 500 mg and 600 mg tablets, is a nonsteroidal anti-inflammatory drug (NSAID). It is indicated for the treatment of osteoarthritis, rheumatoid arthritis, and for the management of pain. The second product, Calcitriol, imported in 0.25mcg and 0.5 mcg capsules, is a synthetic vitamin D analog. It is indicated for the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure. It is also indicated for the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. The last product, Azelastine Hydrochloride Nasal Spray, imported in 137 mcg, is an antihistamine. It is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus. The applicable subheading for Etodolac tablets imported in dosage form will be 3004.90.9128, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Analgesics, antipyretics and nonhormonal anti-inflammatory agents: Other.” The rate of duty will be free. The applicable subheading for the Calcitriol capsules imported in dosage form will be 3004.50.5020, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other medicaments containing vitamins or other products of heading 2936: Other: Other: Single vitamins: Other.” The rate of duty will be free. The applicable subheading for Azelastine Hydrochloride Nasal Spray imported in dosage form will be 3004.90.9180, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Antihistamines.” 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