SYMJEPI (Page 6 of 6)

2-Pack Outer Carton

2-Pack Outer Carton
(click image for full-size original)

NDC #38739-200-12

RX ONLY

Protect from light

SYMJEPI TM

(epinephrine) Injection 0.3 mg

(0.3 mg PRE-FILLED SINGLE DOSE SYRINGE)

For Allergic Emergencies (Anaphylaxis)

USP (0.3mg/ 0.3mL)

PCR-720-07468

6 two-pack units

SYMJEPI
epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:38739-200
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epinephrine (epinephrine) epinephrine 0.3 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride 1.8 mg in 0.3 mL
sodium metabisulfite 0.5 mg in 0.3 mL
hydrochloric acid
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:38739-200-06 6 CARTON in 1 CARTON contains a CARTON (38739-200-01)
1 NDC:38739-200-01 1 SYRINGE in 1 CARTON This package is contained within the CARTON (38739-200-06) and contains a SYRINGE
1 0.3 mL in 1 SYRINGE This package is contained within a CARTON (38739-200-01) and a CARTON (38739-200-06)
2 NDC:38739-200-12 6 CARTON in 1 CARTON contains a CARTON (38739-200-02)
2 NDC:38739-200-02 2 SYRINGE in 1 CARTON This package is contained within the CARTON (38739-200-12) and contains a SYRINGE
2 0.3 mL in 1 SYRINGE This package is contained within a CARTON (38739-200-02) and a CARTON (38739-200-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207534 11/15/2017
Labeler — Adamis Pharmaceuticals Corporation (618661680)
Establishment
Name Address ID/FEI Operations
Catalent Belgium S.A. 370696762 manufacture (38739-200), analysis (38739-200)

Revised: 02/2019 Adamis Pharmaceuticals Corporation

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