ACD-A- anticoagulant citrate dextrose solution a solution

ACD-A by

Drug Labeling and Warnings

ACD-A 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: 796-08

750 mL volume. Single use container.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Store at room temperature.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Not for direct intravenous infusion.

WARNINGS

Avoid excessive heat. Protect from freezing.

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

750 mL volume bag.

Each 100 ml contains:

0.73 g citric acid (anhydrous), USP

2.20 g sodium citrate (dihydrate), USP

2.45 g dextrose (monohydrate), USP

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Hot Stamped Bag

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

ACD-A 
anticoagulant citrate dextrose solution a solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53157-796
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.45 g  in 100 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	SODIUM CITRATE	2.20 g  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	0.73 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53157-796-08	12 in 1 CARTON
1		750 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	NDA710497	11/06/1987

Labeler - Haemonetics Manufacturing Inc (078598396)

Registrant - Haemonetics Manufacturing Inc (078598396)

Establishment
Name	Address	ID/FEI	Business Operations
Haemonetics Manufacturing Inc		078598396	MANUFACTURE(53157-796)