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

PACKAGE CARTON – HUMULIN R U-500 Vial 20 mL 1ct
(click image for full-size original)

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.

Figure
DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT

Figure
(click image for full-size original)
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

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