The tariff classification of Valsartan and Hydrochlorothiazide Tablets, Oxybutynin Chloride Tablets and Ranitidine Injection in dosage form, from India

N238842 March 1, 2013 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9120; 3004.90.9190; 3004.90.9160 Mr. Pradeep Shah Zydus Pharmaceuticals (USA) Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Valsartan and Hydrochlorothiazide Tablets, Oxybutynin Chloride Tablets and Ranitidine Injection in dosage form, from India Dear Mr. Shah: In your letter dated February 5, 2013, you requested a tariff classification ruling. The first product, Valsartan and Hydrochlorothiazide tablets, is a combination of two drugs, an angiotensin receptor blocker (Valsartan) and diuretic (Hydrochlorothiazide). It is indicated for the treatment of hypertension, to lower blood pressure. The second product, Oxybutynin Chloride Extended-release tablets, is an antispasmodic, anticholinergic agent. It is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The last product, Ranitidine Injection, imported in 25 mg/mL is a histamine H2-blocker that inhibits stomach acid production. It is indicated for the treatment of stomach ulcers and gastroesophageal reflux disease (GERD). The applicable subheading for the Valsartan and Hydrochlorothiazide tablets in dosage form will be 3004.90.9120, 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: Cardiovascular medicaments.” The rate of duty will be free. The applicable subheading for the Oxybutynin Chloride Extended-release tablets in dosage form will be 3004.90.9190, 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: Other.” The rate of duty will be free. The applicable subheading for the Ranitidine Injection 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 at (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division