NDC | 0942-9005-01 |
Set ID | bee8e967-496c-4541-b092-ead6c8c80269 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Fenwal Inc. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | BN160918 |
- WARNINGS
- HOW SUPPLIED
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACD-A
antiocoagulant citrate dextrose solution, formula a solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0942-9005 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 2.2 g in 100 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 730 mg in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0942-9005-01 1000 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN160918 10/24/2012 Labeler - Fenwal Inc. (794519020) Registrant - Fenwal Inc. (794519020) Establishment Name Address ID/FEI Business Operations Fenwal International, Inc 091164590 MANUFACTURE(0942-9005)