NDC Code(s) : 50090-6391-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LEVEMIRinsulin detemir INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6391(NDC:0169-6432)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DETEMIR(UNII: 4FT78T86XV)
(INSULIN DETEMIR - UNII:4FT78T86XV) 		INSULIN DETEMIR100 [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)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
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:50090-6391-05 in 1 CARTON 03/09/2023
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 BLA021536 10/31/2013

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-6391)

PRINCIPAL DISPLAY PANEL

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