Humulin R U-500 (Page 5 of 5)

VIAL PACKAGE CARTON – HUMULIN R U-500 Vial 20 mL 1ct

NDC 0002-8501-01

20 mL

Humulin^® R U-500

(insulin human) injection

10,000 units per 20 mL

500 units per mL

Rx only

500 units/mL

Warning — Highly Concentrated

IMPORTANT: Use only with a U-500 syringe.

20 mL multiple-dose vial

For subcutaneous use only

www.humulin.com

Lilly

KWIKPEN PACKAGE CARTON – HUMULIN R U-500 KwikPen 3 mL (500 Units per mL)

Dispense in this sealed carton

NDC 0002-8824-27

Humulin^® R U-500
KwikPen^®

(insulin human)
injection

For Single Patient Use Only

prefilled insulin delivery device

500 units/mL

500 units per mL

2 x 3 mL prefilled pens

Rx only

For subcutaneous use only.

Read Humulin^® R U-500 KwikPen^® Instructions for Use.

NEEDLES NOT INCLUDED

This device is recommended for use with Becton, Dickinson and Company’s insulin pen needles.

DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT

HUMULIN R U-500 insulin human injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-8501 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Insulin human (Insulin human) Insulin human 500 [iU] in 1 mL

Inactive Ingredients Ingredient Name Strength Glycerin 16 mg in 1 mL Metacresol 2.5 mg in 1 mL Zinc 0.085 mg in 1 mL Water Hydrochloric acid Sodium hydroxide

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0002-8501-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0002-8501-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA018780 03/31/1994

HUMULIN R U-500 KWIKPEN insulin human injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-8824 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Insulin human (Insulin human) Insulin human 500 [iU] in 1 mL

Inactive Ingredients Ingredient Name Strength Glycerin 16 mg in 1 mL Metacresol 2.5 mg in 1 mL Zinc 0.085 mg in 1 mL Water Hydrochloric acid Sodium hydroxide

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0002-8824-27 2 SYRINGE in 1 CARTON contains a SYRINGE 1 3 mL in 1 SYRINGE This package is contained within the CARTON (0002-8824-27)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA018780 12/29/2015

Labeler — Eli Lilly and Company (006421325)

Revised: 06/2022 Eli Lilly and Company