NDC Code(s) : 0002-7715-01, 0002-7715-59, 0002-7715-63, 0002-8214-01, 0002-8214-05
Packager : Eli Lilly and Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BASAGLAR Insulin glargine INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-7715
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Insulin glargine(UNII: 2ZM8CX04RZ)
(Insulin glargine - UNII:2ZM8CX04RZ) 		Insulin glargine100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin(UNII: PDC6A3C0OX)17 mg in 1 mL
Metacresol(UNII: GGO4Y809LO)2.7 mg in 1 mL
Zinc oxide(UNII: SOI2LOH54Z)0.03 mg in 1 mL
Hydrochloric acid(UNII: QTT17582CB)
Sodium hydroxide(UNII: 55X04QC32I)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0002-7715-595 in 1 CARTON 17/06/2016
1NDC:0002-7715-013 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0002-7715-631 in 1 CARTON 15/07/2016
23 mL in 1 SYRINGE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA205692 12/16/2015
BASAGLAR Insulin glargine INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-8214
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Insulin glargine(UNII: 2ZM8CX04RZ)
(Insulin glargine - UNII:2ZM8CX04RZ) 		Insulin glargine100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin(UNII: PDC6A3C0OX)17 mg in 1 mL
Metacresol(UNII: GGO4Y809LO)2.7 mg in 1 mL
Zinc oxide(UNII: SOI2LOH54Z)0.03 mg in 1 mL
Hydrochloric acid(UNII: QTT17582CB)
Sodium hydroxide(UNII: 55X04QC32I)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0002-8214-055 in 1 CARTON 15/11/2019
1NDC:0002-8214-013 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA205692 12/16/2015

LABELER - Eli Lilly and Company(006421325)

PRINCIPAL DISPLAY PANEL

PACKAGE CARTON – BASAGLAR KwikPen 80 UNIT PEN

Dispense in this sealed carton.

NDC 0002-7715-59

Basaglar®

KwikPen®

(insulin glargine)
injection

For Single Patient Use Only

100 units per mL (U-100)

For subcutaneous use only

Can inject from 1 to 80 units in a single injection

5 x 3 mL prefilled pens

prefilled insulin delivery device

Rx only

Read Basaglar® KwikPen® Instructions for Use.

NEEDLES NOT INCLUDED

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

Lilly

PACKAGE CARTON – BASAGLAR KwikPen

PRINCIPAL DISPLAY PANEL

PACKAGE CARTON – BASAGLAR Tempo Pen 80 UNIT PEN

Dispense in this sealed carton.

NDC 0002-8214-05

Basaglar®

Tempo Pen™

(insulin glargine)
injection

For Single Patient Use Only

100 units per mL (U-100)

For subcutaneous use only

Can inject from 1 to 80 units in a single injection

5 x 3 mL prefilled pens

prefilled insulin delivery device

Rx only

Read Basaglar® Tempo Pen™ Instructions for Use.

NEEDLES NOT INCLUDED

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

Lilly

PACKAGE CARTON – BASAGLAR Tempo Pen