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Fluoxetine Hydrochloride from Japan

Fluoxetine hydrochloride is the active pharmaceutical ingredient in Prozac, a selective serotonin reuptake inhibitor (SSRI) used primarily as an antidepressant. It contains an unfused pyridine ring in its heterocyclic structure, qualifying it for classification under HTS 2933.39.31.00 as a psychotherapeutic agent.

Duty Rate — Japan → United States

21%

Rate breakdown

9903.04.628.5%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Obtain FDA approval and Drug Master File (DMF) prior to importation as a bulk pharmaceutical chemical

• Provide Certificate of Analysis confirming purity and identity matching pharmacopoeia standards

• Verify compliance with DEA scheduling if applicable, though fluoxetine is not a controlled substance