N260730 N2 Ruling Active

The tariff classification of Xarelto® tablets in dosage form from Germany

Issued January 30, 2015 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9120

Headings: 3004

Product description

The subject product, Xarelto®, imported in 15 mg tablets, is a medicinal preparation containing the active ingredient Rivaroxaban, an anticoagulant. Xarelto® is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

CBP rationale

The applicable subheading for the Xarelto® 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.

Full text

N260730 January 30, 2015 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9120 Mark D. Pinchok Bayer International Trade Services Corporation 651 Colliers Way, Suite 414 Weirton, WV 26062 RE: The tariff classification of Xarelto® tablets in dosage form from Germany Dear Mr. Pinchok: In your letter dated January 8, 2015, on behalf of Bayer HealthCare LLC, you requested a tariff classification ruling. The subject product, Xarelto®, imported in 15 mg tablets, is a medicinal preparation containing the active ingredient Rivaroxaban, an anticoagulant. Xarelto® is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The applicable subheading for the Xarelto® 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. 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 [email protected]. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division

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