EPINEPHRINE (Page 5 of 5)

Revised: March 2023

Manufactured by:

BPI Labs, LLC

12393 S Belcher Road, Suite 450,

Largo, FL 33773

LI18I-I19I-I43I

R-2403

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

1mg-ml-label
(click image for full-size original)

1mg-ml-10pack
(click image for full-size original)
1mg-ml-25pack
(click image for full-size original)
10mg-10ml-viallabel
(click image for full-size original)
10mg-10ml-carton
(click image for full-size original)
30mg-30ml-viallabel
(click image for full-size original)
30mg-30ml-carton
(click image for full-size original)
EPINEPHRINE
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54288-120
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54288-120-01 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (54288-120-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205029 03/16/2022
EPINEPHRINE
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54288-119
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54288-119-10 10 VIAL25 VIAL in 1 CARTON contains a VIAL
1 NDC:54288-119-25 10 VIAL25 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within a CARTON (54288-119-10) and a CARTON (54288-119-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205029 03/07/2024
EPINEPHRINE
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54288-152
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 30 mg in 30 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54288-152-01 1 VIAL in 1 CARTON contains a VIAL
1 30 mL in 1 VIAL This package is contained within the CARTON (54288-152-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205029 03/21/2024
Labeler — BPI Labs, LLC (078627620)
Establishment
Name Address ID/FEI Operations
BPI Labs, LLC 078627620 manufacture (54288-119), manufacture (54288-120), manufacture (54288-152), analysis (54288-119), analysis (54288-120), analysis (54288-152)

Revised: 03/2024 BPI Labs, LLC

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