NDC Code(s) : 0002-8805-01, 0002-8805-59, 0002-8805-99
Packager : Eli Lilly and Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Humulin Insulin human INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-8805
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Insulin human(UNII: 1Y17CTI5SR)
(Insulin human - UNII:1Y17CTI5SR) 		Insulin human100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin(UNII: PDC6A3C0OX)16 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)1.6 mg in 1 mL
Zinc(UNII: J41CSQ7QDS)0.025 mg in 1 mL
Phenol(UNII: 339NCG44TV)0.65 mg in 1 mL
PROTAMINE SULFATE(UNII: 0DE9724IHC)0.35 mg in 1 mL
Sodium phosphate, dibasic(UNII: GR686LBA74)3.78 mg in 1 mL
Water(UNII: 059QF0KO0R)
Hydrochloric acid(UNII: QTT17582CB)
Sodium hydroxide(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0002-8805-595 in 1 CARTON
1NDC:0002-8805-013 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0002-8805-991 in 1 CARTON
23 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018781 11/07/2013

PRINCIPAL DISPLAY PANEL

5x3 mL

prefilled pens

NDC 0002-8805-59

HP-8805

Humulin® N KwikPen®

NPH

human insulin (rDNA origin)

isophane suspension

For Single Patient Use Only

Read Insulin Delivery Device Instructions for Use

For subcutaneous use only.

prefilled insulin delivery device

U-100 100 units per mL

Needles not included

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

Lilly

PACKAGE LABEL – Humulin N KwikPen 3mL 5ct