Dialyvite Supreme D
Dialyvite Supreme D
Approved
Approval ID
46fc3acf-1e6d-4830-ae9a-abd9c1132fca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2022
Manufacturers
FDA
Hillestad Pharmaceuticals USA
DUNS: 029291085
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10542-009
Product Classification
G
Generic Name
Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 24, 2019
FDA Product Classification
INGREDIENTS (21)
Calcium PantothenateActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
BiotinActive
Quantity: 300 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
Zinc CitrateActive
Quantity: 15 mg in 1 1
Code: K72I3DEX9B
Classification: ACTIM
SelenocysteineActive
Quantity: 70 ug in 1 1
Code: 0CH9049VIS
Classification: ACTIM
Calcium StearateInactive
Code: 776XM7047L
Classification: IACT
CholecalciferolActive
Quantity: 2000 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
Thiamine MononitrateActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
Ascorbic AcidActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
RiboflavinActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NiacinamideActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
Pyridoxine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
Folic AcidActive
Quantity: 3 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CobalaminActive
Quantity: 1 mg in 1 1
Code: 8406EY2OQA
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Copper ChlorophyllinInactive
Code: 1D276TYV9O
Classification: IACT
.alpha.-tocopherol succinate, d-Active
Quantity: 30 [iU] in 1 1
Code: LU4B53JYVE
Classification: ACTIM