NDC Code(s) : 67457-843-00, 67457-843-30
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

linezolidlinezolid INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-843
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINEZOLID(UNII: ISQ9I6J12J)
(LINEZOLID - UNII:ISQ9I6J12J) 		LINEZOLID600 mg in 300 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-843-3010 in 1 BOX 31/07/2018
1NDC:67457-843-00300 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205154 07/31/2018 06/30/2024

LABELER - Mylan Institutional LLC(790384502)

PRINCIPAL DISPLAY PANEL

NDC 67457-324-00

100 mL

Linezolid Injection

200 mg/100 mL

(2 mg/mL)

For Intravenous Administration

Rx only

Mylan

Single-Dose Containers

Pouch 200 mg

PRINCIPAL DISPLAY PANEL

NDC 67457-843-00

300 mL

Linezolid Injection

600 mg/300 mL

(2 mg/mL)

For Intravenous Administration

Rx only

Mylan

Single-Dose Containers

Pouch 600 mg