ACD A- dextrose monohydrate, sodium citrate, and citric acid monohydrate injection, solution

ACD by

Drug Labeling and Warnings

ACD by is a Prescription medication manufactured, distributed, or labeled by Terumo BCT Ltd, Terumo BCT Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Catalog # 40800
12 × 750 mL units

NDC: 14537-967-75

DESCRIPTION

Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx Only. Single use container.

For use only with apheresis devices. See apheresis device operator's manual for complete instructions.

Caution

Not for direct intravenous infusion.

Recommended storage

Store up to 25 °C. (See USP Controlled Room Temperature).

Avoid excessive heat. Protect from freezing.

HOW SUPPLIED

Each 100 mL contains:
Dextrose Monohydrate USP	2.45 g
Sodium Citrate Dihydrate USP	2.20 g
Citric Acid Monohydrate USP	0.80 g
In Water for Injection USP

SPL UNCLASSIFIED SECTION

Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA

777967-066

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 12 Bag Case Label

Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution A

Catalog # 40800
12 x 750 mL units

NDC: 14537-967-75

Sterile. Non-pyrogenic. Do not use unless the solution is clear
and the container is intact. Rx Only. Single use container.
For use only with apheresis devices. See apheresis device
operator's manual for complete instructions.

Caution: Not for direct intravenous infusion.

Recommended storage: Store up to 25 °C. (See USP
Controlled Room Temperature).
Avoid excessive heat. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP 2.45 g
Sodium Citrate Dihydrate USP 2.20 g
Citric Acid Monohydrate USP 0.80 g
In Water for Injection USP

Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA

777967-066
TERUMOBCT

Lot
Expiry Date

INGREDIENTS AND APPEARANCE

ACD   A
dextrose monohydrate, sodium citrate, and citric acid monohydrate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 14537-967
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (Sodium Cation - UNII:LYR4M0NH37)	SODIUM CITRATE, UNSPECIFIED FORM	2.2 g  in 100 mL
Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	0.80 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14537-967-75	12 in 1 CASE
1		750 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	BA010228	02/25/2002

Labeler - Terumo BCT Ltd (233649834)

Establishment
Name	Address	ID/FEI	Business Operations
Terumo BCT Ltd.		233649834	MANUFACTURE(14537-967) , STERILIZE(14537-967) , LABEL(14537-967) , ANALYSIS(14537-967)