SODIUM CITRATE- anticoagulant sodium citrate solution solution

Sodium Citrate by

Drug Labeling and Warnings

Sodium Citrate by is a Prescription medication manufactured, distributed, or labeled by Haemonetics Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Re-Order Product Code: 798-60

250 mL volume. Single use container.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Store at room temperature.

INDICATIONS AND USAGE

For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.

CONTRAINDICATIONS

Not for direct intravenous infusion.

WARNINGS

Avoid excessive heat. Protect from freezing. Do NOT vent.

PRECAUTIONS

Do not use unless solution is clear and no leaks detected.

General

Rx only. Discard unused portion.

Recommended Storage: Store at room temperature (25°C / 77°F).

HOW SUPPLIED

250 mL volume bag.

Each 250 ml contains:

10.0 g sodium citrate (dihydrate), USP

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Bag Label

Envelope Label

References

HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

Manufactured for:

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

INGREDIENTS AND APPEARANCE

SODIUM CITRATE 
anticoagulant sodium citrate solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53157-798
Route of Administration	INTRAVENOUS	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	10.0 g  in 250 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53157-798-60	36 in 1 CARTON
1		250 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
NDA	NDA760305	06/30/1978

Labeler - Haemonetics Manufacturing Inc (078598396)

Registrant - Haemonetics Manufacturing Inc (078598396)

Establishment
Name	Address	ID/FEI	Business Operations
Haemonetics Manufacturing Inc		078598396	MANUFACTURE(53157-798) , STERILIZE(53157-798) , LABEL(53157-798)