NDC Code(s) : 0115-1695-30, 0115-1695-49, 0115-1694-30, 0115-1694-49
Packager : Amneal Pharmaceuticals of New York LLC

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:0115-1695
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:0115-1695-301 in 1 CARTON 04/01/2010
11 in 1 CASE
10.15 mL in 1 SYRINGE, GLASS Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0115-1695-492 in 1 CARTON 04/01/2010
21 in 1 CASE
20.15 mL in 1 SYRINGE, GLASS 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 authorized generic NDA020800 04/01/2010
epinephrineepinephrine INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1694
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:0115-1694-301 in 1 CARTON 04/01/2010
11 in 1 CASE
10.3 mL in 1 SYRINGE, GLASS Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0115-1694-492 in 1 CARTON 04/01/2010
21 in 1 CASE
20.3 mL in 1 SYRINGE, GLASS 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 authorized generic NDA020800 04/01/2010

LABELER - Amneal Pharmaceuticals of New York LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Boehringer Ingelheim Pharma GmbH and Co. KG 551147440 api manufacture(0115-1695, 0115-1694)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 analysis(0115-1695, 0115-1694), manufacture(0115-1695, 0115-1694)

Establishment
Name Address ID/FEI Business Operations
PPD Development, L.P. 838082055 analysis(0115-1695, 0115-1694)

PRINCIPAL DISPLAY PANEL

1

PRINCIPAL DISPLAY PANEL

1

PRINCIPAL DISPLAY PANEL

1

PRINCIPAL DISPLAY PANEL

1