HEPARIN SODIUM AND SODIUM CHLORIDE- heparin sodium injection, solution

Heparin Sodium and Sodium Chloride by

Drug Labeling and Warnings

Heparin Sodium and Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Healthcare Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROVIDER LETTER

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

Code B0953G
500 ml
Baxter Logo
Heparin Sodium BP 2000 IU/L in
0.9% w/v Sodium Chloride IV Infusion

VIAFLEX container

Sterile nonpyrogenic
Solution for Infusion
Single Dose

Each 500 ml contains
Heparin Sodium (Mucous) 1000 IU
Sodium Chloride 4.5 g
Disodium Phosphate 12H 2 0 2.9 g
Citric Acid (Monohydrate) 0.202g
Water for Injections

mmol per 500 ml (approx)
Sodium 93
Chloride 77
Phosphate 8
Citrate 1

For intravenous administration
Store out of reach and sight of children
Do not remove from overwrap until ready for use
Do not use unless solution is clear and container is
undamaged
Do not add any supplementary medication
For use under medical supervision
Do not store above 25°C
Discard any unused portion
Do not reconnect partially used bags
Baxter Healthcare Ltd
Thetford Norfolk IP24 3SE
PL00116/0130
POM symbol
Heparin Sodium BP 2000 IU/L in
0.9% w/v Sodium Chloride
IV Infusion
TH-35-01-749
Lot
Expiry
1
2
3
4

Container Label

Code B0944
1000 ml
Baxter Logo
Heparin Sodium BP 2000 IU/L in
0.9% w/v Sodium Chloride IV Infusion

VIAFLEX container
Sterile nonpyrogenic
Solution for Infusion
Single Dose

•   Each 1000 ml contains
  Heparin Sodium (Mucous) 2000 IU
  Sodium Chloride 9 g
  Disodium Phosphate 12H 2 0 5.8 g
  Citric Acid (Monohydrate) 0.405 g
  Water for Injections

mmol per 1000 ml (approx)
Sodium 186
Chloride 154
Phosphate 16
Citrate 2

For intravenous administration
Store out of reach and sight of children
Do not remove from overwrap until ready for
use
Do not use unless solution is clear and container
is undamaged
Do not add any supplementary medication
For use under medical supervision
Do not store above 25°C
Discard any unused portion
Do not reconnect partially used bags

Baxter Healthcare Ltd
Thetford Norfolk IP24 3SE
PL00116/0130
POM symbol
TH-35-01-237

Heparin Sodium BP 2000 IU/L in
0.9% w/v Sodium Chloride
IV Infusion
Lot
Expiry
1
2
3
4
5
6
7
8
9

INGREDIENTS AND APPEARANCE

HEPARIN SODIUM AND SODIUM CHLORIDE 
heparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9556
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)	HEPARIN	1000 [iU]  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	4.5 g  in 500 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)	2.9 g  in 500 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.202 g  in 500 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9556-20	20 in 1 CARTON	10/25/2017
1		500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/25/2017

HEPARIN SODIUM AND SODIUM CHLORIDE 
heparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9552
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)	HEPARIN	2000 [iU]  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9 g  in 1000 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)	5.8 g  in 1000 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.405 g  in 1000 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9552-10	10 in 1 CARTON	10/25/2017
1		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/25/2017

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Ltd		221478644	ANALYSIS(0338-9556, 0338-9552) , MANUFACTURE(0338-9556, 0338-9552) , LABEL(0338-9556, 0338-9552) , PACK(0338-9556, 0338-9552) , STERILIZE(0338-9556, 0338-9552)