3004.90.92.16/Tacrolimus 1mg Capsules/Japan

Tacrolimus 1mg Capsules from Japan

Tacrolimus capsules are immunosuppressive medicaments used to prevent organ transplant rejection, containing 1mg of the active ingredient in hard gelatin capsules for oral measured doses. Classified under HTS 3004.90.92.16 for retail-packed immunosuppressive products.

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)

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Import Tips

• Submit bioequivalence studies if generic to support ANDA status with FDA

• Label in English with full prescribing information per FD&C Act requirements

• Avoid delays by pre-submitting entry with controlled substance schedules if applicable