SODIUM CHLORIDE- sodium chloride injection 
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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Sodium Chloride Intravenous Infusion BP 0.9% w/v

HEALTH CARE PROVIDER LETTER

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Represenative container label 50 mL.jpg

Container Label

Code B0042

50 ml

Baxter Logo

MINIBAG PLUS

Sodium Chloride 0.9% w/v
Intravenous Infusion BP

Sterile – Nonpyrogenic – Isotonic
Solution for Infusion Single dose

Osmolarity 308 m0sm/l (approx)
Mmol per 50ml (approx)
Sodium 7.7 Chloride 7.7 pH 5 (approx)
Hydrochloric Acid qs Water for Injection qs
Sodium Hydroxide qs

IV administration
Read package leaflet before use.
Keep out of the sight and reach of children.
Sterile – Nonpyrogenic – Isotonic
Single dose Do not use unless solution is clear,
free from visible particles and container is
undamaged Check additive compatibility before
use For use under medical supervision Discard any
unused portion Do not reconnect partially used bags
Do not store above 25°C

VIAFLEX container

POM symbol

PL0116/5057

Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

Lot

5413760020907

EXP

CB-35-04-229

Representative Container Label 100 mL

Container Label

Code B0043

100 ml

Baxter Logo

MINIBAG PLUS

Sodium Chloride 0.9% w/v
Intravenous Infusion BP

Sterile – Nonpyrogenic – Isotonic
Solution for Infusion Single dose

Osmolarity 308 m0sm/l (approx)
Mmol per 50ml (approx)
Sodium 15.4 Chloride 15.4 pH 5 (approx)
Hydrochloric Acid qs Water for Injection qs
Sodium Hydroxide qs

IV administration
Read package leaflet before use.
Keep out of the sight and reach of children.
Sterile – Nonpyrogenic – Isotonic
Single dose Do not use unless solution is clear,
free from visible particles and container is
undamaged Check additive compatibility before
use For use under medical supervision Discard any
unused portion Do not reconnect partially used bags
Do not store above 25°C

VIAFLEX container

POM symbol

PL0116/5057

Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

Lot

5413760020914

EXP

CB-35-04-230

SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9613
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE450 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9613-3030 in 1 CARTON10/05/201707/31/2018
150 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 shortage10/05/201707/31/2018
SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9616
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9616-3030 in 1 CARTON10/05/201703/31/2019
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 shortage10/05/201703/31/2019
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare S.A.988899845ANALYSIS(0338-9616) , LABEL(0338-9616) , MANUFACTURE(0338-9616) , PACK(0338-9616) , STERILIZE(0338-9616)

Revised: 10/2018
Document Id: 160d95e9-5618-44e4-8cd5-58f467a6769c
Set id: bb20c158-87af-4d19-bc07-16dbd8e6e1f0
Version: 3
Effective Time: 20181022
 
Baxter Healthcare Corporation