NDC Code(s) : 42023-159-01, 42023-159-25, 42023-168-01
Packager : ENDO USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Adrenalinepinephrine INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-159
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE(UNII: YKH834O4BH)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)7.3 mg in 1 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.457 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)1 mg in 1 mL
TARTARIC ACID(UNII: W4888I119H)2.25 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.20 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-159-2525 in 1 CARTON 07/01/2013
1NDC:42023-159-011 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
NDA NDA204200 07/01/2013
Adrenalinepinephrine INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-168
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE(UNII: YKH834O4BH)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)6.15 mg in 1 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.457 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)0.920 mg in 1 mL
TARTARIC ACID(UNII: W4888I119H)2.25 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.20 mg in 1 mL
CHLOROBUTANOL(UNII: HM4YQM8WRC)5.25 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-168-011 in 1 CARTON 03/01/2014
130 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
NDA NDA204640 03/01/2014

LABELER - ENDO USA, Inc.(119185057)

PRINCIPAL DISPLAY PANEL

1 mL Vial Label

NDC 42023-159-01
Rx Only

Adrenalin®
(epinephrine injection, USP)

1 mg/mL

For Intravenous Infusion, Intramuscular and Subcutaneous Use

NOT for Ophthalmic Use

1 mL Single Dose Vial

1 mL Vial Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 mL Vial Label

NDC 42023-168-01
Rx Only

Adrenalin®
(epinephrine injection, USP)

30 mg/30 mL

(1 mg/mL)

For Intravenous Infusion, Intramuscular and S ubcutaneous Use

NOT for Ophthalmic Use

30 mL Multiple Dose Vial

30 mL Vial Label

PRINCIPAL DISPLAY PANEL

1 mL Carton

NDC 42023-159-25
Rx Only

Adrenalin®
(epinephrine injection, USP)

1 mg/mL

For Intravenous Infusion, Intramuscular and Subcutaneous Use

NOT for Ophthalmic Use

1 mL Carton

PRINCIPAL DISPLAY PANEL

30 mL Carton

NDC 42023-168-01
Rx Only

Adrenalin®
(epinephrine injection, USP)

30 mg/mL

For Intravenous Infusion, Intramuscular and Subcutaneous Use

NOT for Ophthalmic Use

30 mL Carton