![ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD]](https://medic.hrt.org//dailymed/images/570770de-9b48-4fc1-a1ee-06002ca9504f/acd-a-01.jpg)
| NDC | 14537-967-75 |
| Set ID | 570770de-9b48-4fc1-a1ee-06002ca9504f |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Terumo BCT Ltd |
| Generic Name | |
| Product Class | Anti-coagulant |
| Product Number | |
| Application Number | ANDA010228 |
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- Caution
- Recommended storage
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 12 Bag Case Label
Anticoagulant Citrate Dextrose
Solution USP (ACD) Solution ACatalog # 40800
12 x 750 mL unitsNDC 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 USPManufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA777967-066
TERUMOBCTLot
Expiry Date
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INGREDIENTS AND APPEARANCE
ACD A
dextrose monohydrate, sodium citrate, and citric acid monohydrate injection, solutionProduct 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)