N303571 N3 Ruling Active

The tariff classification of Acyclovir Sodium Injection and Acetazolamide Tablets in dosage form, from India

Issued April 10, 2019 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9285, 3004.90.9210

Headings: 3004

Product description

Acyclovir Sodium Injection is a medicinal preparation containing Acyclovir Sodium, an antiviral, as the active ingredient. It is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Acetazolamide, imported in 125 mg and 250 mg tablets, is a carbonic anhydrase inhibitor. It is indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.

CBP rationale

The applicable subheading for the Acyclovir Sodium Injection 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 applicable subheading for the Acetazolamide Tablets in dosage form will be 3004.90.9285, 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: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.

Full text

N303571 April 10, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9210; 3004.90.9285 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Acyclovir Sodium Injection and Acetazolamide Tablets in dosage form, from India Dear Mr. Shah: In your letter dated March 21, 2019, you requested a tariff classification ruling. Acyclovir Sodium Injection is a medicinal preparation containing Acyclovir Sodium, an antiviral, as the active ingredient. It is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Acetazolamide, imported in 125 mg and 250 mg tablets, is a carbonic anhydrase inhibitor. It is indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent. The applicable subheading for the Acyclovir Sodium Injection 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. The applicable subheading for the Acetazolamide Tablets in dosage form will be 3004.90.9285, 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: Medicaments primarily affecting the eyes, ears or respiratory system: 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 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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