Tresiba (Page 9 of 9)

Storage

Keep in a cold place until first use. After first use store between 36 to 86 degrees F. Protect from light.

insulin degludec injection

Label ImageLabel Image
TRESIBA insulin degludec injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3491(NDC:0169-2550)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DEGLUDEC (INSULIN DEGLUDEC) INSULIN DEGLUDEC 200 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 19.6 mg in 1 mL
PHENOL 1.50 mg in 1 mL
METACRESOL 1.72 mg in 1 mL
ZINC 71.9 ug in 1 mL
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3491-0 3 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC
1 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (50090-3491-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA203314 09/25/2015
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3491)

Revised: 05/2022 A-S Medication Solutions

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