NDC Code(s) : 51662-1290-1, 51662-1290-2, 51662-1290-3
Packager : HF Acquisition Co LLC, DBA HealthFirst

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ADRENALIN (EPINEPHRINE)ADRENALIN (EPINEPHRINE) INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1290(NDC:42023-159)
Route of Administration INTRAMUSCULAR, 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 HYDROXIDE(UNII: 55X04QC32I)1 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)7.3 mg in 1 mL
TARTARIC ACID(UNII: W4888I119H)2.25 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.457 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.2 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51662-1290-11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product21/09/2018
2NDC:51662-1290-325 in 1 CASE 29/04/2020
2NDC:51662-1290-21 mL in 1 POUCH Type 0: Not a Combination Product21/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204200 09/21/2018

LABELER - HF Acquisition Co LLC, DBA HealthFirst(045657305)

REGISTRANT - HF Acquisition Co LLC, DBA HealthFirst(045657305)

Establishment
Name Address ID/FEI Business Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel(51662-1290)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

NDC 42023-159-25
Rx Only

Adrenalin®
(epinephrine
injection, USP)

1 mg/mL

NOT for Ophthalmic Use

1 mL Single-Use Vial

1 mL VIAL

Adrenalin 1 mL vial label

PRINCIPAL DISPLAY PANEL

RFID Label

PRINCIPAL DISPLAY PANEL

NDC 51662-1290-2 Pouch Label

Pouch label

PRINCIPAL DISPLAY PANEL

NDC 51662-1290-3 Case Label

Case Label

PRINCIPAL DISPLAY PANEL

SERIALIZED LABEL