NDC Code(s) : 54505-101-01, 54505-101-02, 54505-102-01, 54505-102-02
Packager : Lineage Therapeutics Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

epinephrineepinephrine INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54505-101
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE(UNII: YKH834O4BH)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE0.15 mg in 0.15 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CHLOROBUTANOL(UNII: HM4YQM8WRC)
SODIUM BISULFITE(UNII: TZX5469Z6I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54505-101-011 in 1 CARTON 01/04/2010
11 in 1 CASE
10.15 mL in 1 SYRINGE, GLASS Type 0: Not a Combination Product
2NDC:54505-101-022 in 1 CARTON 01/04/2010
21 in 1 CASE
20.15 mL in 1 SYRINGE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020800 04/01/2010 04/30/2018
epinephrineepinephrine INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54505-102
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE(UNII: YKH834O4BH)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE0.3 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CHLOROBUTANOL(UNII: HM4YQM8WRC)
SODIUM BISULFITE(UNII: TZX5469Z6I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54505-102-011 in 1 CARTON 01/04/2010
11 in 1 CASE
10.3 mL in 1 SYRINGE, GLASS Type 0: Not a Combination Product
2NDC:54505-102-022 in 1 CARTON 01/04/2010
21 in 1 CASE
20.3 mL in 1 SYRINGE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020800 04/01/2010 05/31/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.15 mg CARTON NDC 54505-101-02
Rx Only
Lineage Therapeutics
epinephrine injection, USP
auto-injector
0.15 mg
For Allergic Emergencies
in patients weighing 33 lb – 66 lb
For Subcutaneous or Intramuscular Use Only
This carton contains: Two epinephrine auto-injectors

Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.15 mg WRAP LABEL
Lineage Therapeutics
epinephrine injection, USP
auto-injector
0.15 mg


Wrap Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.15 mg CASE LABEL
epinephrine injection, USP
auto-injector
0.15 mg
Lineage Therapeutics

Case Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.3 mg CARTON NDC 54505-102-02
Rx Only
Lineage Therapeutics
epinephrine injection, USP
auto-injector
0.3 mg
For Allergic Emergencies
in patients weighing over 66 lb
For Subcutaneous or Intramuscular Use Only
This carton contains: Two epinephrine auto-injectors

Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.3 mg WRAP LABEL
Lineage Therapeutics
epinephrine injection, USP
auto-injector
0.3 mg

Wrap Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 0.3 mg CASE LABEL
epinephrine injection, USP
auto-injector
0.3 mg
Lineage Therapeutics

Case Label