NDC Code(s) : 50090-4500-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4500(NDC:0169-6339)
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(INSULIN ASPART - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.25 mg in 1 mL
GLYCERIN(UNII: PDC6A3C0OX)16 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
METACRESOL(UNII: GGO4Y809LO)1.72 mg in 1 mL
PHENOL(UNII: 339NCG44TV)1.5 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ZINC(UNII: J41CSQ7QDS)19.6 ug in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-4500-05 in 1 CARTON 09/04/2019
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020986 01/22/2003

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-4500)

PRINCIPAL DISPLAY PANEL

Label Image