Levemir FlexTouch Insulin Pen
Levemir FlexTouch delivers insulin detemir, a long-acting basal insulin analog for diabetes glycemic control. Each 3mL cartridge (100 units/mL) in the pen allows precise measured dosing for retail patient use. Classified in 3004.31.00.00 as insulin hormone medicament in measured retail form.
Import Duty Rates by Country of Origin
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If other synthetic hormone medicaments not specifically insulin
If formulation analysis shows non-insulin hormone dominance, moves to residual synthetic category.
If imported as diagnostic reagent containing insulin for lab testing
Chapter exclusion places diagnostic reagents of insulin in 3822, not therapeutic medicaments.
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Import Tips & Compliance
• Biosimilar insulins need additional FDA abbreviated new drug application data for import
• Declare pen mechanism separately if reusable; only disposable pre-filled units stay in 3004
• Cold chain validation critical—thermal mapping data prevents 'adulterated' FDA holds
Related Products under HTS 3004.31.00.00
Humalog Insulin KwikPen
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.
Toujeo SoloStar Insulin Pen
Toujeo SoloStar contains insulin glargine U300, a concentrated long-acting insulin for once-daily diabetes dosing. The 1.5mL pre-filled pen (300 units/mL) provides measured doses for retail sale. HTS 3004.31.00.00 covers this high-strength insulin formulation.
Tresiba FlexTouch Insulin Pen
Tresiba FlexTouch provides ultra-long-acting insulin degludec for diabetes basal insulin therapy. Available in U100 (3mL, 100 units/mL) and U200 (3mL, 200 units/mL) pre-filled pens with measured dosing. Falls under HTS 3004.31.00.00 as retail-packaged insulin medicaments.
Novolin 70/30 Prefilled Insulin Syringe
Novolin 70/30 is a pre-mixed human insulin suspension (70% NPH, 30% regular) in disposable 0.3mL, 0.5mL, or 1mL syringes with fixed needles. Provides measured doses for retail diabetic patient use. HTS 3004.31.00.00 includes mixed insulin formulations in therapeutic doses.
Humulin R U-500 KwikPen
Humulin R U-500 is concentrated regular insulin (500 units/mL) in KwikPens for severe insulin-resistant diabetes patients. The 3mL pen delivers measured high doses for retail therapeutic use. Classified under 3004.31.00.00 as potent insulin medicament.
Lantus SoloStar Insulin Pen
Lantus SoloStar is a long-acting insulin glargine injection for basal glycemic control in type 1 and type 2 diabetes. Each pre-filled pen delivers 3mL of 100 units/mL insulin in measured doses for patient self-administration. Falls under HTS 3004.31.00.00 as a mixed insulin product put up for retail therapeutic use.