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 0.9% w/v Intravenous Infusion, BP, in VIAFLO container

HEALTH CARE PROVIDER LETTER

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

Baxter Logo

FE1306G

Viaflo Logo
50 ml

Sodium Chloride 0.9% w/v
Intravenous Infusion BP

: Isotonic
pH 5.5 (approx)
Osmolarity 308 m0sm/l (approx.)
Formula per 50 ml
mmol/l per 50 ml (approx)
Sodium Chloride 0.45 g
Sodium 7.7
Water for Injections
Chloride 7.7
IV administration

Read package leaflet before use Keep out of sight and
reach of children Do not remove from overwrap until ready
for use Do not use unless solution is clear without visible
particles, and container undamaged Do not reconnect
partially used bags Do not store above 30°C
Baxter Healthcare Ltd Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

POM symbol

PA167/008/015
MA161/00403
PL00116/0334

UN-35-03-132

0 085412 578453

LOT EXP

Container Label

Baxter Logo

FE1307

Viaflo Logo
100 ml

Sodium Chloride 0.9% w/v
Intravenous Infusion BP

: Isotonic
pH 5.5 (approx)
Osmolarity 308 m0sm/l (approx.)
Formula per 100 ml
mmol/l per 100 ml (approx)
Sodium Chloride 0.9 g
Sodium 15.4
Water for Injections
Chloride 15.4
IV administration

Read package leaflet before use
Keep out of sight and reach of children Do not
remove from overwrap until ready for use Do not use
unless solution is clear without visible particles, and
container undamaged Do not reconnect partially
used bags Do not store above 30°C
Baxter Healthcare Ltd Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

POM symbol

PA167/008/015
MA161/00403
PL00116/0334

UN-35-03-134

5413760277677

LOT EXP

SODIUM CHLORIDE
sodium chloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0338-9546
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.45 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0338-9546-50	75 in 1 CARTON	10/05/2017	11/30/2019
1		50 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug for use in drug shortage		10/05/2017	11/30/2019

SODIUM CHLORIDE
sodium chloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0338-9550
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.9 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0338-9550-50	50 in 1 CARTON	10/05/2017	02/28/2020
1		100 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug for use in drug shortage		10/05/2017	02/28/2020

Labeler - Baxter Healthcare Corporation (005083209)

Name	Address	ID/FEI	Business Operations
Establishment
Baxter Healthcare S.A.		988899845	ANALYSIS(0338-9546, 0338-9550) , LABEL(0338-9546, 0338-9550) , MANUFACTURE(0338-9546, 0338-9550) , PACK(0338-9546, 0338-9550) , STERILIZE(0338-9546, 0338-9550)

Revised: 2/2020

Document Id: 80049aeb-22ef-45c7-85e5-60cfeb7b30d3

Set id: 641e08ee-8706-47e1-b3ce-210ce4d33099

Version: 7

Effective Time: 20200228

Baxter Healthcare Corporation