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Dialyvite 5000

Dialyvite 5000

Approved
Approval ID

97791f73-e0c5-45a6-8aed-f456a5466eaf

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

NDC Product Code10542-011
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateOctober 24, 2019
Generic NameAscorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium

INGREDIENTS (20)

Ascorbic AcidActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
Thiamine MononitrateActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
NiacinamideActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
Folic AcidActive
Quantity: 5 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
BiotinActive
Quantity: 300 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CobalaminActive
Quantity: 2 mg in 1 1
Code: 8406EY2OQA
Classification: ACTIB
SelenocysteineActive
Quantity: 70 ug in 1 1
Code: 0CH9049VIS
Classification: ACTIM
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Zinc CitrateActive
Quantity: 25 mg in 1 1
Code: K72I3DEX9B
Classification: ACTIM
ShellacInactive
Code: 46N107B71O
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
BlueberryInactive
Code: 253RUG1X1A
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Calcium StearateInactive
Code: 776XM7047L
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
RiboflavinActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
Pyridoxine HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
Calcium PantothenateActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
.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: 10/14/2022

PRINCIPAL DISPLAY PANEL

NDC 10542-011-09

Dialyvite 5000

Multivitamin Supplement for Dialysis Patients

90 Tablets

Dialyvite 3000 PDP

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Dialyvite 5000 - FDA Drug Approval Details