MedPath
FDA Approval

Dialyvite with Zinc

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Hillestad Pharmaceuticals USA
DUNS: 029291085
Effective Date
October 14, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nicotinamide(20 mg in 1 1)
Pyridoxine(10 mg in 1 1)
Vitamin C(100 mg in 1 1)
Riboflavin(1.7 mg in 1 1)
Vitamin B12(6 ug in 1 1)
Pantothenic acid(10 mg in 1 1)
Folic acid(1 mg in 1 1)
Biotin(300 ug in 1 1)
Zinc citrate(50 mg in 1 1)
Thiamine(1.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Hillestad Pharmaceuticals USA

Hillestad Pharmaceuticals USA

029291085

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dialyvite with Zinc

Product Details

NDC Product Code
10542-012
Route of Administration
ORAL
Effective Date
October 23, 2019
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 10 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 100 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Code: 8406EY2OQAClass: ACTIBQuantity: 6 ug in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 300 ug in 1 1
Microcrystalline CelluloseInactive
Code: OP1R32D61UClass: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
Code: K72I3DEX9BClass: ACTIMQuantity: 50 mg in 1 1
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
ShellacInactive
Code: 46N107B71OClass: IACT
Starch, CornInactive
Code: O8232NY3SJClass: IACT
Calcium StearateInactive
Code: 776XM7047LClass: IACT
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.5 mg in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 10542-012-10

Dialyvite with Zinc

Multivitamin Supplement for Dialysis Patients

100 Tablets

Dialyvite with Zinc PDP


© Copyright 2025. All Rights Reserved by MedPath