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N306528 N3 Ruling Active

The tariff classification of Nitrofurantoin Capsules USP (monohydrate/macrocrystals) in dosage form, from Taiwan

Issued October 30, 2019 by U.S. Customs and Border Protection.

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N3 N306528 (October 30, 2019)

Tariff classification

HTS codes: 3004.90.9210

Headings: 3004

Product description

Nitrofurantoin Capsules USP (monohydrate/macrocrystals), imported in 100 mg, is an antibacterial medicament. It is indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.

CBP rationale

The applicable subheading for the Nitrofurantoin Capsules USP (monohydrate/macrocrystals) 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

N306528 October 30, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9210 Ms. Paulina Radaczynska BluePoint Laboratories 8 Eastgate Avenue, Eastgate Business Park Little Island, Cork, T45 NF24 Ireland RE: The tariff classification of Nitrofurantoin Capsules USP (monohydrate/macrocrystals) in dosage form, from Taiwan Dear Ms. Radaczynska: In your letter dated October 2, 2019, you requested a tariff classification ruling. Nitrofurantoin Capsules USP (monohydrate/macrocrystals), imported in 100 mg, is an antibacterial medicament. It is indicated for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. The applicable subheading for the Nitrofurantoin Capsules USP (monohydrate/macrocrystals) 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 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

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