FDA.reportPublic FDA data

0.9% Sodium Chloride Injection (VIAFLEX Container)

Manufacturer
Baxter Healthcare Corporation | Baxter Hospitalar Ltda.
Effective date
2018-01-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:21:41

Label at a glance#

ProductSODIUM CHLORIDE
Active ingredientSODIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Health Care Provider Letter

HEALTH CARE PROVIDER LETTER SECTION

Dear DHCP Letter_image 01
Dear DHCP Letter_image 01
Dear DHCP Letter_image 02
Dear DHCP Letter_image 02
Dear DHCP Letter_image 03
Dear DHCP Letter_image 03
Dear DHCP Letter_image 04
Dear DHCP Letter_image 04

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative Container Label 500 mL
Representative Container Label 500 mL

BATCH
EXP
0.9% SODIUM CHLORIDE
500 mL
VIAFLEX
CLOSURE SYSTEM
STORE AT ROOM TEMPERATURE (15°C TO 30°C)
ADULT AND PEDIATRIC USE
EACH 100ML CONTAINS
SODIUM CHLORIDE 900MG WATER FOR INJECTION SUFFICIENT
QUANTITY TO 100ML SODIUM 154 MEQ/L CHLORIDE 154 MEQ/L
pH APPROX 5.0 OSMOLARITY APPROX 308 mOsml/L
INTRAVENOUS ADMINISTRATION STERILE NONPYROGENIC SOLUTION
DO NOT USE IF TURBIDITY IS PRESENT SINGLE USE DISCARD AFTER USE
INFORMATION TO THE HEALTHCARE PROFESSIONAL
INDICATIONS CONTRAINDICATIONS AND PRECAUTIONS
REFER TO PACKAGE INSERT
ALL MEDICINES SHOULD BE KEPT OUT OF THE REACH OF CHILDREN
REMOVE THE OVERPOUCH FOR USE
LATEX FREE PRODUCT
RESTRICTED USE FOR HOSPITALS
SALE UNDER MEDICAL PRESCRIPTION
BAXTER Logo
BAXTER HOSPITALAR LTDA
HENRI DUNANT STREET 1383 12º FLOOR TOWER B
CONJ 1201 E 1204 SÃO PAULO SP BRAZIL
CNPJ 49351786000180 BRAZILIAN INDUSTRY
LICENSE NUMBER 1068300690198
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
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300
400
FZB1323
28 25 01 506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9517-16ML - Milliliter0338-951783cb9abc-5eff-43e4-b07a-c4479318802212018-03-08
0338-9517-50ML - Milliliter0338-9517e92e0e06-d5e9-4811-88ed-768ebdd74f4c12018-07-03

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-95170338-9517-50, 0338-9517-30, 0338-9517-16

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB

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
139e990d-427f-4d52-9844-63e93ec362048a91c5f5-c52c-4750-82b5-6bd716485a542018-01-31Exact identifier
spl set id: 8a91c5f5-c52c-4750-82b5-6bd716485a54

Reported adverse events (FAERS/openFDA)#

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