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NDC 10542-0012-10 Dialyvite with Zinc 100; 300; 10; 6; 1; 20; 10; 1.7; 1.5; 50 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

Dialyvite with Zinc 100; 300; 10; 6; 1; 20; 10; 1.7; 1.5; 50 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Dialyvite with Zinc is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hillestad Pharmaceuticals USA. The primary component is ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC CITRATE.

Product Information

NDC	10542-0012
Product ID	10542-012_a4bb0842-ce2a-4f47-83f9-260d434a4c7c
Associated GPIs	78136000000330
GCN Sequence Number	065338
GCN Sequence Number Description	B complex 11/folic/C/biot/zinc TABLET 1 MG-100MG ORAL
HIC3	C6B
HIC3 Description	VITAMIN B PREPARATIONS
GCN	23079
HICL Sequence Number	036432
HICL Sequence Number Description	VITAMIN B COMPLEX NO.11/FOLIC ACID/VIT C/BIOTIN/ZINC OXIDE
Brand/Generic	Brand
Proprietary Name	Dialyvite with Zinc
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	100; 300; 10; 6; 1; 20; 10; 1.7; 1.5; 50
Active Ingredient Units	mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Substance Name	ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC CITRATE
Labeler Name	Hillestad Pharmaceuticals USA
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10542-0012-10 (10542001210)

Pricing Information	N/A
NDC Package Code	10542-012-10
Billing NDC	10542001210
Package	100 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-012-10)
Marketing Start Date	2002-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 06508e37-5ae6-4a17-bf60-b3828c6082a7 Details

DESCRIPTION

Dialyvite with Zinc is a prescription folic acid supplement with zinc and additional nutrients for kidney dialysis patients. Dialyvite with Zinc is a small, round, yellow, clear-coated tablet, with debossed "H" on one side.

Each tablet contains:

Folic Acid.....1 mg

Vitamin C (Ascorbic Acid).....100 mg

Thiamine (Thiamine Mononitrate).....1.5 mg

Riboflavin.....1.7 mg

Niacinamide.....20 mg

Vitamin B6 (Pyridoxine HCl).....10 mg

Vitamin B12 (Methylcobalamin).....6 mcg

Biotin.....300 mcg

Pantothenic Acid (Calcium Pantothenate).....10 mg

Zinc (Zinc Citrate).....50 mg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Calcium Stearate.

INDICATIONS AND USAGE

Dialyvite with Zinc is a prescription folic acid supplement with Zinc and additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

CONTRAINDICATIONS

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.

Keep out of reach of children.

ADVERSE REACTIONS

Allergic sensitizations have been reported following oral administration of folic acid.

Consult your physician immediately if adverse side effects occur.

DOSAGE AND ADMINISTRATION

Take one tablet per day or as directed by your physician, orally.

PRINCIPAL DISPLAY PANEL

NDC 10542-012-10

Dialyvite with Zinc

Multivitamin Supplement for Dialysis Patients

100 Tablets

INGREDIENTS AND APPEARANCE

DIALYVITE WITH ZINC

ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10542-012
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	100 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.5 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.7 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine	10 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA)	Cobalamin	6 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	300 ug
Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737)	Pantothenic Acid	10 mg
Zinc Citrate (UNII: K72I3DEX9B) (Zinc Cation - UNII:13S1S8SF37)	Zinc Cation	50 mg

Ingredient Name	Strength
Inactive Ingredients
Microcrystalline Cellulose (UNII: OP1R32D61U)
Croscarmellose Sodium (UNII: M28OL1HH48)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Shellac (UNII: 46N107B71O)
Starch, Corn (UNII: O8232NY3SJ)
Calcium Stearate (UNII: 776XM7047L)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	H
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10542-012-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2002
2	NDC:10542-012-02	7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		10/01/2002

Labeler - Hillestad Pharmaceuticals USA (029291085)

Name	Address	ID/FEI	Business Operations
Establishment
Hillestad Pharmaceuticals USA		029291085	manufacture(10542-012) , pack(10542-012) , label(10542-012)

Revised: 10/2022

Document Id: a4bb0842-ce2a-4f47-83f9-260d434a4c7c

Set id: 06508e37-5ae6-4a17-bf60-b3828c6082a7

Version: 4

Effective Time: 20221014