BYNFEZIA Pen (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only
NDC 62756-452-37
Bynfezia PenTM (octreotide acetate Injection)
2,500 mcg/mL
Two 2.8 mL disposable single-patient-use prefilled pens
Subcutaneous use only
For doses of 50 mcg, 100 mcg, 150 mcg, and 200 mcg.
For Single Patient Use Only SUN PHARMA

spl-octreotide-carton
(click image for full-size original)
BYNFEZIA PEN octreotide acetate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-452
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID 3.4 mg in 1 mL
MANNITOL 22.5 mg in 1 mL
PHENOL 5 mg in 1 mL
SODIUM BICARBONATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62756-452-37 2 CARTRIDGE in 1 CARTON contains a CARTRIDGE
1 2.8 mL in 1 CARTRIDGE This package is contained within the CARTON (62756-452-37)
2 NDC:62756-452-36 1 CARTRIDGE in 1 CARTON contains a CARTRIDGE
2 2.8 mL in 1 CARTRIDGE This package is contained within the CARTON (62756-452-36)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213224 04/29/2020
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (62756-452), MANUFACTURE (62756-452)

Revised: 02/2020 Sun Pharmaceutical Industries, Inc.

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