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N195837 N1 Ruling Active

The tariff classification of Amoxicillin Potassium Clavulanate Tablets imported in dosage form, from India

Issued December 13, 2011 by U.S. Customs and Border Protection.

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N1 N195837 (December 13, 2011)

Tariff classification

HTS codes: 3004.10.5045

Headings: 3004

Product description

Amoxicillin Potassium Clavulanate is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the ß-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). It is indicated for use in the treatment of bacterial infections including streptococcal pharyngitis, pneumonia, urinary tract infections, and skin infections.

CBP rationale

The applicable subheading for the Amoxicillin Potassium Clavulanate Tablets in dosage form will be 3004.10.5045, 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: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives: Other: Other: Combination antibiotics.

Full text

N195837 December 13, 2011 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.10.5045 Ms. Martha Scott NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road Cork, Ireland RE: The tariff classification of Amoxicillin Potassium Clavulanate Tablets imported in dosage form, from India Dear Ms. Scott: In your letter dated December 5, 2011, you requested a tariff classification ruling. Amoxicillin Potassium Clavulanate is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the ß-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). It is indicated for use in the treatment of bacterial infections including streptococcal pharyngitis, pneumonia, urinary tract infections, and skin infections. The applicable subheading for the Amoxicillin Potassium Clavulanate Tablets in dosage form will be 3004.10.5045, 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: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives: Other: Other: Combination antibiotics.” 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 the National Import Specialist Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division

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