Pediatric Infuvite Multiple Vitamins for Infusion is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Canada Inc. The primary component is Ascorbic Acid; Vitamin A Palmitate; Cholecalciferol; Thiamine Hydrochloride; Riboflavin 5'-phosphate Sodium; Pyridoxine Hydrochloride; Niacinamide; Dexpanthenol; Alpha-tocopherol Acetate; Phytonadione; Folic Acid; Biotin; Cyanocobalamin.
| Product ID | 54643-5646_2e3c2e71-a3b8-48bf-8e95-96299424cad5 |
| NDC | 54643-5646 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Pediatric Infuvite Multiple Vitamins for Infusion |
| Generic Name | Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Fo |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2001-02-21 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021265 |
| Labeler Name | Sandoz Canada Inc |
| Substance Name | ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; ALPHA-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN |
| Active Ingredient Strength | 80 mg/5mL; [iU]/5mL; [iU]/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL; mg/5mL; ug/5mL; ug/5mL; ug/5mL |
| Pharm Classes | Vitamin C [EPC],Ascorbic Acid [CS],Vitamin A [CS],Vitamin A [EPC],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |