NDC Code(s) : 0024-5924-10, 0024-5925-01, 0024-5925-05, 0024-5925-00, 0024-5926-05
Packager : Sanofi-Aventis U.S. LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ADMELOGinsulin lispro INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5924
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN LISPRO(UNII: GFX7QIS1II)
(INSULIN LISPRO - UNII:GFX7QIS1II) 		INSULIN LISPRO100 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)16 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)1.88 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)3.15 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)0.0197 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:0024-5924-101 in 1 CARTON 12/11/2017
110 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA209196 12/11/2017
ADMELOGinsulin lispro INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5925
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN LISPRO(UNII: GFX7QIS1II)
(INSULIN LISPRO - UNII:GFX7QIS1II) 		INSULIN LISPRO100 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)16 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)1.88 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)3.15 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)0.0197 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:0024-5925-055 in 1 CARTON 12/11/2017
1NDC:0024-5925-013 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0024-5925-001 in 1 CARTON 12/11/2017
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
BLA BLA209196 12/11/2017
ADMELOGinsulin lispro INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5926
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN LISPRO(UNII: GFX7QIS1II)
(INSULIN LISPRO - UNII:GFX7QIS1II) 		INSULIN LISPRO100 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)16 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)1.88 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)3.15 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)0.0197 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:0024-5926-051 in 1 CARTON 19/10/2018
13 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA209196 10/19/2018

LABELER - Sanofi-Aventis U.S. LLC(824676584)

Establishment
Name Address ID/FEI Business Operations
Sanofi-Aventis Deutschland GmbH 313218430 ANALYSIS(0024-5924, 0024-5925, 0024-5926), MANUFACTURE(0024-5924, 0024-5925, 0024-5926), API MANUFACTURE(0024-5924, 0024-5925, 0024-5926), PACK(0024-5924, 0024-5925, 0024-5926), LABEL(0024-5924, 0024-5925, 0024-5926)

PRINCIPAL DISPLAY PANEL

NDC 0024-5924-10
Rx only

Admelog®
(insulin lispro) injection

100 units/mL (U-100)

For subcutaneous use

For intravenous infusion
after further dilution ONLY
under direct medical
supervision

Use only with a U-100 syringe

10mL multiple-dose vial

sanofi

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

PRINCIPAL DISPLAY PANEL

Rx only

NDC 0024-5925-05

Admelog® SoloStar®
(insulin lispro) injection
For Single Patient Use Only

100 units/mL (U-100)

For subcutaneous use only

Do not mix with other insulins

Five 3 mL prefilled pens

Dispense in this sealed carton

sanofi

PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton

PRINCIPAL DISPLAY PANEL

NDC 0024-5926-05
Rx only

Admelog®
(insulin lispro) injection

100 units/mL (U-100)

For subcutaneous use

For intravenous infusion
after further dilution ONLY
under direct medical
supervision

Use only with a U-100 syringe

3mL multiple-dose vial

sanofi

PRINCIPAL DISPLAY PANEL - 3 mL Vial Carton