Label: ANTICOAGULANT CITRATE DEXTROSE A ACD-A injection, solution
- NDC Code(s): 43203-852-47
- Packager: Arteriocyte Medical Systems, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 17, 2018
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SPL UNCLASSIFIED SECTION
ACD-A 50 mL
Catalog # AMSACD-AAnticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See Operator's Manuals for additional information and complete usage instructions.
Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact and undamaged.
Rx only. Single use container.
- Caution
- Recommended storage
- Each 10mL contains
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label
Anticoagulant Citrate Dextrose Solution,
Solution A USP ACD-A50 mL
50 x 50 mLCatalog # AMSACD-A
Anticoagulant intended for use only with devices that prepare Platelet Rich
Plasma (PRP) products for extracorporeal use. See Operator's Manuals for
additional information and complete usage instructions.Sterile. Non-pyrogenic. Do not use unless the solution is clear and the
container is intact and undamaged. Rx only. Single use container.Caution: Not for preparation of blood products for transfusion or for direct
intravenous infusion.Storage Conditions: Room temperature (68° to 77°F, 20° to 25°C)
Avoid excessive heat. Protect from freezing. Protect from direct sunlight.Each 10mL contains:
Citric Acid Monohydrate USP
0.08 g
Sodium Citrate Dihydrate USP
0.220 g
Dextrose Monohydrate USP
0.245 g
In Water for Injection USPManufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMSLot
Expiry Date
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INGREDIENTS AND APPEARANCE
ANTICOAGULANT CITRATE DEXTROSE A ACD-A
anticoagulant citrate dextrose a acd-a injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43203-852 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.08 g in 10 mL SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE, UNSPECIFIED FORM 0.220 g in 10 mL DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 0.245 g in 10 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) 9.76 g in 10 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43203-852-47 50 in 1 CASE 1 1 in 1 POUCH 1 50 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 BA110057 05/11/2011 Labeler - Arteriocyte Medical Systems, Inc. (809012870) Registrant - Terumo BCT, Inc. (801679200) Establishment Name Address ID/FEI Business Operations Terumo BCT, Ltd. 233649834 MANUFACTURE(43203-852) , ANALYSIS(43203-852) , STERILIZE(43203-852) , LABEL(43203-852)