FDA.reportPublic FDA data

Metronidazole

Manufacturer
Baxter Healthcare Corporation | Baxter Healthcare S.A.
Effective date
2019-10-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:03:56

Label at a glance#

ProductMetronidazole
Active ingredientMETRONIDAZOLE
Label structure2 sections

Label contents#

Full prescribing information#

HEALTH CARE PROVIDER LETTER

HEALTH CARE PROVIDER LETTER SECTION

DHCP Letter 1
DHCP Letter 1
DHCP Letter 2
DHCP Letter 2
DHCP Letter 3
DHCP Letter 3
DHCP Letter 4
DHCP Letter 4
DHCP Letter 5
DHCP Letter 5
DHCP Letter 6
DHCP Letter 6
DHCP Letter 7
DHCP Letter 7
DHCP Letter 8
DHCP Letter 8
DHCP Letter 9
DHCP Letter 9
DHCP Letter 10
DHCP Letter 10
DHCP Letter 11
DHCP Letter 11
DHCP Letter 12
DHCP Letter 12
DHCP Letter 13
DHCP Letter 13
DHCP Letter 14
DHCP Letter 14

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Metronidazole Container label
Metronidazole Container label

Baxter Logo
Viaflo Logo

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00303389616306GTIN-14: 00303389616306
GTIN-12: 303389616306
UPC-A: 303389616306
EAN-13: 0303389616306
GTIN storage (14 digits): 00303389616306		image 14.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9554-50ML - Milliliter0338-955473c3363c-3f8c-452e-a6df-8182671c77a112017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-95540338-9554-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
METRONIDAZOLE140QMO216EACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATEE1W4N241FOIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f57ac74f-73a5-4eec-ba6f-667a91739b8d49cf6773-965a-440a-b5bb-6ac015dffd082019-10-31Exact identifier
spl id: f57ac74f-73a5-4eec-ba6f-667a91739b8d
spl set id: 49cf6773-965a-440a-b5bb-6ac015dffd08

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.