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Dialyvite with Zinc

Dialyvite with Zinc

Approved
Approval ID

06508e37-5ae6-4a17-bf60-b3828c6082a7

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, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10542-012
Product Classification
G
Generic Name
Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2019
FDA Product Classification

INGREDIENTS (16)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/14/2022

PRINCIPAL DISPLAY PANEL

NDC 10542-012-10

Dialyvite with Zinc

Multivitamin Supplement for Dialysis Patients

100 Tablets

Dialyvite with Zinc PDP

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