Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION
Product Details
NDC Product Code
54643-5646Application Number
NDA021265Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
March 28, 2016Vitamin D3Active
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 5 mL
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 80 mg in 5 mL
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 5 mL
DexpanthenolActive
Code: 1O6C93RI7ZClass: ACTIBQuantity: 5 mg in 5 mL
Palmitic AcidActive
Code: 1D1K0N0VVCClass: ACTIMQuantity: 2300 [iU] in 5 mL
Code: 20RD1DZH99Class: ACTIMQuantity: 1.4 mg in 5 mL
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 1 mg in 5 mL
NicotinamideActive
Code: 25X51I8RD4Class: ACTIBQuantity: 17 mg in 5 mL
Vitamin K1Active
Code: A034SE7857Class: ACTIBQuantity: 0.2 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: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
alpha-Tocopherol acetateActive
Code: 9E8X80D2L0Class: ACTIBQuantity: 7 [iU] in 5 mL