insulin degludec injection injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2550
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DEGLUDEC (UNII: 54Q18076QB) (INSULIN DEGLUDEC - UNII:54Q18076QB) INSULIN DEGLUDEC 200 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX) 19.6 mg in 1 mL
PHENOL (UNII: 339NCG44TV) 1.50 mg in 1 mL
METACRESOL (UNII: GGO4Y809LO) 1.72 mg in 1 mL
ZINC (UNII: J41CSQ7QDS) 71.9 ug in 1 mL
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0169-2550-13 3 in 1 CARTON
1 3 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
2 NDC:0169-2550-97 1 in 1 CARTON
2 3 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203314 09/25/2015
Labeler - Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305914798 MANUFACTURE(0169-2660, 0169-2550)
Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305156788 API MANUFACTURE(0169-2660, 0169-2550)
