Pediatric Infuvite Multiple Vitamins

Product NDC
54643-7886
11-digit product format
546437886
Labeler code
54643
Product ID
54643-7886_a2d6735d-ba42-4c15-9dc9-90e18f15e443
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
NDA021265
Marketing category
NDA
Marketing start
2001-02-21
Marketing end
0000-00-00
Substance
.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE
Active strength
7 [iU]/5mL; mg/5mL; ug/5mL; [iU]/5mL; ug/5mL; mg/5mL; ug/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54643-7886-1ML - Milliliter54643-7886191776df-3663-4a48-8a27-47916ec7e4b012017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54643-7886PEDIATRIC INFUVITE MULTIPLE VITAMINS (ASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMIN) KIT PEDIATRIC INFUVITE MULTIPLE VITAMINS (ASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMIN) INJECTION, SOLUTION [SANDOZ INC]6Legacy NDC20221129_02064c66-3f2d-4502-a96d-800a4d128593.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54643-7886-15464378860110 VIAL in 1 CARTON (54643-7886-1) > 5 mL in 1 VIAL10 vial2016-12-230000-00-00NoNoCurrent