N331876 N3 Ruling Active

The tariff classification of Daptomycin Injection in dosage form, from China

Issued April 21, 2023 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.20.0060

Headings: 3004

Product description

Daptomycin, imported in 350 mg and 500 mg injectable vials, is a cyclic lipopeptide antibiotic. It is used to treat complicated skin and skin structure infections by susceptible Gram-positive bacteria and bacteremia due to Staphylococcus aureus.

CBP rationale

The applicable subheading for the Daptomycin Injection in dosage form will be 3004.20.0060, 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, containing antibiotics: Other: Other.

Full text

N331876 April 21, 2023 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Carol Glenny Avila NorthStar Healthcare UC 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Daptomycin Injection in dosage form, from China Dear Ms. Glenny Avila: In your letter dated March 30, 2023, you requested a tariff classification ruling. Daptomycin, imported in 350 mg and 500 mg injectable vials, is a cyclic lipopeptide antibiotic.  It is used to treat complicated skin and skin structure infections by susceptible Gram-positive bacteria and bacteremia due to Staphylococcus aureus. The applicable subheading for the Daptomycin Injection in dosage form will be 3004.20.0060, 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, containing antibiotics: Other: 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 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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division

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