N331809 N3 Ruling Active

The tariff classification of Quetiapine Fumarate Tablets in dosage form, from India

Issued April 12, 2023 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9235

Headings: 3004

Product description

Quetiapine Fumarate, imported in 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets, is in a class of medications called atypical antipsychotics. It is indicated for the treatment of schizophrenia, acute manic or depressive episodes associated with bi-polar disorder, and major depressive disorder (MDD).

CBP rationale

The applicable subheading for the Quetiapine Fumarate Tablets in dosage form will be 3004.90.9235, 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: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.

Full text

N331809 April 12, 2023 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9235 Carol Glenny Avila NorthStar Healthcare UC 3300 Cork Airport Business Park, Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Quetiapine Fumarate Tablets in dosage form, from India Dear Ms. Glenny Avila: In your letter dated March 28, 2023, you requested a tariff classification ruling. Quetiapine Fumarate, imported in 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets, is in a class of medications called atypical antipsychotics.  It is indicated for the treatment of schizophrenia, acute manic or depressive episodes associated with bi-polar disorder, and major depressive disorder (MDD). The applicable subheading for the Quetiapine Fumarate Tablets in dosage form will be 3004.90.9235, 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: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.”  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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