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Hydralazine-Isosorbide Fixed Combination 37.5/20mg Tablets from Japan

Combination tablets with hydralazine 37.5mg and isosorbide dinitrate 20mg for heart failure in African-American patients (BiDil). Classified under HTS 3004.90.92.20 due to primary hydralazine content as specified cardiovascular medicament.

Duty Rate — Japan → United States

15%

Rate breakdown

9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate
9903.05.860%Universal product exemption (U.S. note 52(b))
9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)

Import Tips

Justify principal active (hydralazine) for specific subheading classification

Include interaction studies for fixed-dose combo approval