N270805 N2 Ruling Active

The tariff classification of Bosentan Tablets in dosage form, from India

Issued December 4, 2015 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9120

Headings: 3004

Product description

The subject product, Bosentan Tablets in 62.5 mg and 125 mg, is a medicinal preparation containing Bosentan, an endothelin receptor antagonist, as the active ingredient. It is indicated for the treatment of pulmonary arterial hypertension.

CBP rationale

The applicable subheading for Bosentan 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.

Full text

N270805 December 4, 2015 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9120 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Bosentan Tablets in dosage form, from India Dear Mr. Shah: In your letter dated November 12, 2015, you requested a tariff classification ruling. The subject product, Bosentan Tablets in 62.5 mg and 125 mg, is a medicinal preparation containing Bosentan, an endothelin receptor antagonist, as the active ingredient. It is indicated for the treatment of pulmonary arterial hypertension. The applicable subheading for Bosentan 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.” 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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