NDC Code(s) : 50090-0497-0
Packager : A-S Medication Solutions

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Novolin Human Insulin INJECTION, SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0497(NDC:0169-1833)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN(UNII: 1Y17CTI5SR)
(INSULIN HUMAN - UNII:1Y17CTI5SR) 		INSULIN HUMAN100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ZINC(UNII: J41CSQ7QDS)21 ug in 1 mL
GLYCERIN(UNII: PDC6A3C0OX)16 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)3 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0497-01 in 1 CARTON 28/11/2014
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019938 06/25/1991

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-0497)

PRINCIPAL DISPLAY PANEL

Label Image