NDC Code(s) : 0338-9542-01, 0338-9542-02, 0338-9542-03, 0338-9542-04, 0338-9542-05, 0338-9542-06
Packager : Baxter Healthcare Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sodium Chloridesodium chloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9542
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(CHLORIDE ION - UNII:Q32ZN48698) 		SODIUM CHLORIDE9 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0338-9542-01250 mL in 1 BAG
2NDC:0338-9542-02500 mL in 1 BAG
3NDC:0338-9542-031000 mL in 1 BAG
4NDC:0338-9542-04250 mL in 1 BAG
5NDC:0338-9542-05500 mL in 1 BAG
6NDC:0338-9542-061000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 04/21/2014

PRINCIPAL DISPLAY PANEL

Representative Container Label 250 mLContainer Label

Baxter Logo
Viaflo Logo
FE1322
250 ml

Sodium Chloride 0.9% w/v
Intravenous Infusion BP
Isotonic
pH 5.5 (approx) Osmolarity 308 mOsm/l (approx)
Formula per 250 ml mmol per 250 ml (approx)
Sodium Chloride 2.25 g Sodium 38.5
Water for Injections Chloride 38.5
IV administration
Read package leaflet before use
Keep out of the reach and sight 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

Baxter Healthcare Ltd
Thetford Norfolk IP24 3SE
United Kingdom

PL00116/0334
PA167/8/15
MA161/00403

PDM

07

Bar Code
5413760277691

LOT

EXP

LN-35-01-667 1

Representative Container Label 250 mLCarton Label

FE1322
30 x 250 ml
(= 9.5 kg)

Sodium Chloride 0.9% w/v
Intravenous Infusion BP

Formula per 250 ml
Sodium Chloride 2.25 g
Water for Injections
Osmolarity 308 mOsm/l (approx)
mmol per 250 ml (approx)
Sodium 38.5
Chloride 38.5
pH: 5.5 (approx)
IV administration.
Read package leaflet before use.
Keep out of the reach and sight of children.
Do not reconnect partially used bags.
PL00116/0334
PA167/8/15
MA161/00403

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

Viaflo Logo

P111E547
XX-0001

LOT: XXXXXXXX
EXP: XXXXXXXX

Bar Code
(01)55413760277696(17)XXXX00(10)XXXXXXXX

FE1322

30 X 250 ML

(= 9.5 kg)

Sodium
Chloride 0.9% w/v

Intravenous Infusion BP

Viaflo Logo

LOT:
XXXXXXXX
EXP:
XXXXXXXX