NovoLog FlexPen Insulin
NovoLog FlexPen contains rapid-acting insulin aspart for mealtime blood glucose control in diabetic patients. The pre-filled 3mL pen (100 units/mL) provides dialable measured doses suitable for retail sale. HTS 3004.31.00.00 applies to this insulin-containing medicament in therapeutic dose form.
Import Duty Rates by Country of Origin
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If contains alkaloids rather than hormones (misformulated product)
Alkaloid-based medicaments have separate subheading; insulin is distinctly hormones of 2937.
If classified as immunological product like insulin conjugates for immunotherapy
Chapter note 2 defines immunological products including certain protein conjugates, potentially shifting from general medicaments.
If syringe component dominates over insulin content
Disposable syringes classify under medical instruments if drug content is secondary to delivery mechanism.
Not sure which classification is right?
Our AI classifier can analyze your specific product and recommend the correct HTS code with confidence.
Import Tips & Compliance
• EU/US insulin imports often qualify for zero duty under pharmaceutical appendices or FTAs—verify HS preferences
• Include GMP certificates and stability data; FDA may require comparative dissolution profiles for biosimilars
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.
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.
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.