The tariff classification of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in dosage form and Droxidopa Capsules in dosage form, from India

N314836 October 26, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9210; 3004.90.9220 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in dosage form and Droxidopa Capsules in dosage form, from India Dear Mr. Shah: In your letter dated September 28, 2020, you requested a tariff classification ruling. Emtricitabine and Tenofovir Disoproxil Fumarate, imported in 100 mg/150 mg, 133 mg/200 mg, 167 mg/25 mg, 200 mg/300 mg, is a fixed-dose combination tablet containing Emtricitabine (FTC) and Tenofovir Disoproxil Fumarate (TDF). It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. Droxidopa, imported in 100 mg, 200 mg and 300 mg capsules, is a synthetic amino acid precursor of norepinephrine. It is indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease (PD), multiple system atrophy and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. The applicable subheading for the Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in dosage form will be 3004.90.9210, 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: Anti-infective medicaments: Other.” The rate of duty will be free. The applicable subheading for the Droxidopa Capsules in dosage form will be 3004.90.9220, 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 the World Wide Web at https://hts.usitc.gov/current. 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, Steven A. Mack Director National Commodity Specialist Division