Anticoagulant Citrate Dextrose

Anticoagulant Citrate Dextrose
SPL v5
SPL
SPL Set ID 570770de-9b48-4fc1-a1ee-06002ca9504f
Route
INTRAVENOUS
Published
Effective Date 2025-01-22
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dextrose (2.45 g) Sodium Cation (2.2 g) Anhydrous Citric Acid (0.80 g)

Identifiers & Packaging

Marketing Status
ANDA Active Since 2002-02-25

Description

Catalog # 40800 12 × 750 mL units NDC 14537-967-75


Medication Information

Dosage Forms and Strengths
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
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.

Section 42229-5

Catalog # 40800

12 × 750 mL units

NDC 14537-967-75

Caution

Not for direct intravenous infusion.

Recommended Storage

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

Avoid excessive heat. Protect from freezing.

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


Structured Label Content

Dosage Forms and Strengths (34069-5)
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
Description (34089-3)

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.

Section 42229-5 (42229-5)

Catalog # 40800

12 × 750 mL units

NDC 14537-967-75

Caution

Not for direct intravenous infusion.

Recommended Storage (Recommended storage)

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

Avoid excessive heat. Protect from freezing.

Principal Display Panel 12 Bag Case Label (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


Advanced Ingredient Data


Raw Label Data

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