The tariff classification of Lansoprazole Delayed-release disintegrating tablets, Lansoprazole delayed release capsules and Omeprazole Delayed-release capsules, imported in dosage form, from India

N232956 September 21, 2012 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9160 Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Lansoprazole Delayed-release disintegrating tablets, Lansoprazole delayed release capsules and Omeprazole Delayed-release capsules, imported in dosage form, from India Dear Mr. Shah: In your letter dated August 30, 2012, you requested a tariff classification ruling. The first two products, Lansoprazole Delayed-release capsules and Lansoprazole Delayed release disintegrating tablets, in 15 mg and 30 mg are medicinal preparations containing Lansoprazole, a proton-pump inhibitor (PPI), as the active ingredient. Both products are indicated for the treatment of duodenal ulcer. The last product, Omeprazole Delayed-release capsules, in 10 mg, 20 mg and 40 mg, is a medicinal preparation containing Omeprazole, a proton-pump inhibitor (PPI), as the active ingredient. It is indicated for the treatment of gastroesophageal reflux disease (GERD), gastric and duodenal ulcers. The applicable subheading for the Lansoprazole Delayed-release capsules, Lansoprazole Delayed release disintegrating tablets and Omeprazole Delayed-release capsules in dosage form will be 3004.90.9160, 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 digestive 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 (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division