Dialyvite 3000
Dialyvite 3000
Approved
Approval ID
0bf5d3b9-5931-4180-9517-19977b58fe9a
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, Tocopheryl Acid Succinate, 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 Code10542-014
Product Classification
G
Generic Name
Ascorbic Acid, Tocopheryl Acid Succinate, 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 (20)
Pyridoxine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
RiboflavinActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
Calcium PantothenateActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
Folic AcidActive
Quantity: 3 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CobalaminActive
Quantity: 1 mg in 1 1
Code: 8406EY2OQA
Classification: ACTIB
SelenocysteineActive
Quantity: 70 ug in 1 1
Code: 0CH9049VIS
Classification: ACTIM
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
CarobInactive
Code: 5MG5Z946UO
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Thiamine MononitrateActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
NiacinamideActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
BiotinActive
Quantity: 300 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
ShellacInactive
Code: 46N107B71O
Classification: IACT
Calcium StearateInactive
Code: 776XM7047L
Classification: IACT
Zinc CitrateActive
Quantity: 15 mg in 1 1
Code: K72I3DEX9B
Classification: ACTIM
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Ascorbic AcidActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
.alpha.-tocopherol succinate, d-Active
Quantity: 30 [iU] in 1 1
Code: LU4B53JYVE
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 10/24/2019
PRINCIPAL DISPLAY PANEL
NDC 10542-014-09
Dialyvite 3000
Multivitamin Supplement for Dialysis Patients
90 Tablets
