Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pediatric Infuvite Multiple Vitamins
Product Details
NDC Product Code
54643-9023Application Number
NDA021265Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
October 28, 2016Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 80 mg in 5 mL
Palmitic AcidActive
Code: 1D1K0N0VVCClass: ACTIMQuantity: 2300 [iU] in 5 mL
Vitamin D3Active
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 5 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 1.4 mg in 5 mL
DexpanthenolActive
Code: 1O6C93RI7ZClass: ACTIBQuantity: 5 mg in 5 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 5 mL
Vitamin K1Active
Code: A034SE7857Class: ACTIBQuantity: 0.2 mg in 5 mL
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 1 mg in 5 mL
NicotinamideActive
Code: 25X51I8RD4Class: ACTIBQuantity: 17 mg in 5 mL
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 140 ug in 5 mL
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 20 ug in 5 mL
Vitamin B12Active
Code: P6YC3EG204Class: ACTIBQuantity: 1 ug in 5 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 50 mg in 5 mL
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 75 mg in 5 mL
alpha-Tocopherol acetateActive
Code: 9E8X80D2L0Class: ACTIBQuantity: 7 [iU] in 5 mL
Pediatric Infuvite Multiple Vitamins
Product Details
NDC Product Code
54643-9031Application Number
NDA021646Marketing Category
NDA (C73594)Effective Date
October 28, 2016