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N303889 N3 Ruling Active

The tariff classification of Ampicillin Injection and Ampicillin and Sulbactam Injection in dosage form, from Italy

Issued May 9, 2019 by U.S. Customs and Border Protection.

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N3 N303889 (May 9, 2019)

Tariff classification

HTS codes: 3004.10.5060, 3004.10.5045

Headings: 3004

Product description

Ampicillin Injection, imported in 1 gram vials, is a penicillin-type antibiotic. It is indicated for the treatment of a variety of bacterial infections. Ampicillin and Sulbactam Injection, imported in 1.5 gram vials, is a medicinal preparation containing a mixture of ampicillin sodium, a penicillin-type antibiotic and Sulbactam Sodium, a beta-lactamase inhibitor, as the active ingredients. It is indicated for the treatment of a variety of bacterial infections.

CBP rationale

The applicable subheading for the Ampicillin Injection in dosage form will be 3004.10.5060, 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: Other. The applicable subheading for the Ampicillin and Sulbactam Injection in dosage form will be 3004.10.5045, 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

N303889 May 9, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.10.5045; 3004.10.5060 Ms. Robyn K. Brunciak WorldGen LLC 120 Route 17 North Paramus, NJ 07652 RE: The tariff classification of Ampicillin Injection and Ampicillin and Sulbactam Injection in dosage form, from Italy Dear Ms. Brunciak: In your letter dated April 10, 2019, you requested a tariff classification ruling. Ampicillin Injection, imported in 1 gram vials, is a penicillin-type antibiotic. It is indicated for the treatment of a variety of bacterial infections. Ampicillin and Sulbactam Injection, imported in 1.5 gram vials, is a medicinal preparation containing a mixture of ampicillin sodium, a penicillin-type antibiotic and Sulbactam Sodium, a beta-lactamase inhibitor, as the active ingredients. It is indicated for the treatment of a variety of bacterial infections. The applicable subheading for the Ampicillin Injection in dosage form will be 3004.10.5060, 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: Other.” The rate of duty will be free. The applicable subheading for the Ampicillin and Sulbactam Injection in dosage form will be 3004.10.5045, 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 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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