3004.31.00.00/Humalog Insulin KwikPen/Mexico

Humalog Insulin KwikPen from Mexico

Humalog is a rapid-acting insulin lispro injection used for managing blood sugar levels in diabetes patients. It is put up in pre-filled KwikPen devices containing measured doses of 3mL (100 units/mL) for retail sale. Classified under HTS 3004.31.00.00 as a medicament containing insulin, a hormone of heading 2937, in measured doses for therapeutic use.

Duty Rate — Mexico → United States

100%

Rate breakdown

9903.04.60100%Except as provided in heading 9903.04.61, patented pharmaceutical articles as provided for in subdivisions (c) and (d) of U.S. note 40 to this subchapter

9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter

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Import Tips

• Verify insulin concentration and formulation match declared specs; FDA requires exact NDC codes on commercial invoice

• Include certificates of pharmaceutical product (CPP) and free sale certificates from country of origin for FDA import clearance

• Avoid misclassification as unmixed insulin (3004.90); ensure packaging shows measured doses for retail to qualify under 3004.31