NDC Code(s) : 50090-6565-0
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, SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-6565(NDC:0169-3004)
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
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)
GLYCERIN(UNII: PDC6A3C0OX)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
PROTAMINE SULFATE(UNII: 0DE9724IHC)
ZINC(UNII: J41CSQ7QDS)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-6565-05 in 1 CARTON 18/07/2023
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 BLA019959 09/06/2019

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-6565)

PRINCIPAL DISPLAY PANEL

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