METRONIDAZOLE- metronidazole injection, solution 
Baxter Healthcare Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Metronidazole 500 mg/100 ml Intravenous Infusion

HEALTH CARE PROVIDER LETTER

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Metronidazole Container label

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FE3400

Metronidazole
500 mg/100 ml
Intravenous Infusion
100 ml

Iso-osmotic
Sterile nonpyrogenic
Single dose
Osmolarity

Solution for infusion
pH 4.5 – 6.0 (approx)
308 m0smol/l (approx.)

Each 100 ml contains
Metronidazole 500 mg and also includes Citric acid
monohydrate Disodium phosphate dodecahydrate, Sodium
chloride and Water for Injections
For intravenous administration
Store out of sight and reach of children Do not use unless
solution is clear and container is undamaged Additions should
not be made to this solution unless compatibility is known For
use under medical supervision Discard any unused portion Do
not use in a series of connection Do not reconnect partially
used bags Store in the original overpouch Do not remove unit
from the overpouch until ready to use Protect from light
Keep container in the outer carton
Baxter Healthcare Ltd.,
Thetford
Norfolk, England
PL00116/0353
POM Symbol

UN-35-03-268
Bar Code
5 413760277752

Lot
Expiry

METRONIDAZOLE 
metronidazole injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9554
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE500 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATE (UNII: E1W4N241FO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9554-5050 in 1 CARTON10/05/201710/31/2019
1100 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage10/05/201710/31/2019
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare S.A.988899845ANALYSIS(0338-9554) , MANUFACTURE(0338-9554) , LABEL(0338-9554) , STERILIZE(0338-9554)

Revised: 10/2019
 
Baxter Healthcare Corporation