Label: ACD-A- anticoagulant citrate dextrose solution a solution
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- NDC Code(s): 53157-796-08
- Packager: Haemonetics Manufacturing Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 9, 2015
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- DESCRIPTION
Re-Order Product Code: 796-08
750 mL volume. Single use container.
Sterile, nonpyrogenic fluid path. Sterilized by steam.
Store at room temperature.
Close - 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.
Close - CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
Do not use unless solution is clear and no leaks detected.
CloseGeneral
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
Close - PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
- 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
Close - INGREDIENTS AND APPEARANCE
ACD-A
anticoagulant citrate dextrose solution a solutionProduct 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) CloseEstablishment Name Address ID/FEI Business Operations Haemonetics Manufacturing Inc 078598396 MANUFACTURE(53157-796)
