The tariff classification of Entecavir tablets in dosage form, from Ireland
Issued April 4, 2017 by U.S. Customs and Border Protection.
Tariff classification
HTS codes: 3004.90.9210
Headings: 3004
Product description
Entecavir tablets, is an antiviral medication containing Entecavir, a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor, as the active ingredient. It is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets will be imported in dosages of 0.5 mg and 1 mg.
CBP rationale
The applicable subheading for the Entecavir 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.
Full text
N284591 April 4, 2017 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9210 Ms. Laura Walsh EirGen Pharma Ltd. Westside Business Park Old Kilmeaden Road, Waterford Ireland RE: The tariff classification of Entecavir tablets in dosage form, from Ireland Dear Ms. Walsh: In your letter dated March 20, 2017, you requested a tariff classification ruling. Entecavir tablets, is an antiviral medication containing Entecavir, a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor, as the active ingredient. It is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets will be imported in dosages of 0.5 mg and 1 mg. The applicable subheading for the Entecavir 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. 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 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
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