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5,5-Diphenylhydantoin (Phenytoin Base) from Japan

The active pharmaceutical base form of the anticonvulsant phenytoin, a classic hydantoin derivative. Classified under HTS 2933.21.00.00 for its unfused imidazole ring structure as a separate chemically defined organic compound per Chapter 29 note (a).

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

• Submit FDA bulk drug substance notification with DMF reference,Include USP/NF or EP certificate of analysis confirming identity and purity,Prevent confusion with sodium salt form which may have different documentation