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NDC 10542-0014-09 Dialyvite 3000 30; 100; 300; 10; 1; 3; 20; 25; 1.7; 70; 1.5; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Details

Dialyvite 3000 30; 100; 300; 10; 1; 3; 20; 25; 1.7; 70; 1.5; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1

Dialyvite 3000 is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hillestad Pharmaceuticals USA. The primary component is .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOCYSTEINE; THIAMINE MONONITRATE; ZINC CITRATE.

Product Information

NDC	10542-0014
Product ID	10542-014_678d4ca4-b412-4904-8bb1-c58d54d2719b
Associated GPIs	78137000000330
GCN Sequence Number	054647
GCN Sequence Number Description	folic acid/B cplx/C/selen/zinc TABLET 3MG-15MG ORAL
HIC3	C6B
HIC3 Description	VITAMIN B PREPARATIONS
GCN	22637
HICL Sequence Number	026342
HICL Sequence Number Description	FOLIC ACID/VITAMIN B COMP AND C/SELENIUM/MINERALS/ZINC
Brand/Generic	Brand
Proprietary Name	Dialyvite 3000
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	30; 100; 300; 10; 1; 3; 20; 25; 1.7; 70; 1.5; 15
Active Ingredient Units	[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOCYSTEINE; 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 10542-0014-09 (10542001409)

Pricing Information	N/A
NDC Package Code	10542-014-09
Billing NDC	10542001409
Package	90 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-014-09)
Marketing Start Date	2004-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0bf5d3b9-5931-4180-9517-19977b58fe9a Details

DESCRIPTION

Dialyvite 3000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite 3000 is a small, round, light brown, clear-coated tablet, with debossed "H" on one side.

Each tablet contains:

Folic Acid.....3 mg

Vitamin E (d-alpha Tocopheryl Acid Succinate).....30 IU

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

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

Riboflavin.....1.7 mg

Niacinamide.....20 mg

Vitamin B6 (Pyridoxine HCl).....25 mg

Vitamin B12 (Methylcobalamin).....1 mg

Biotin.....300 mcg

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

Zinc (Zinc Citrate).....15 mg

Selenium (Selenium Amino Acid Chelate).....70 mcg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Carob (color), Starch, Calcium Stearate, Silicon Dioxide.

INDICATIONS AND USAGE

Dialyvite 3000 is a prescription folic acid supplement with 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 use as directed by your physician, orally.

PRINCIPAL DISPLAY PANEL

NDC 10542-014-09

Dialyvite 3000

Multivitamin Supplement for Dialysis Patients

90 Tablets

INGREDIENTS AND APPEARANCE

DIALYVITE 3000

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10542-014
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	25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	3 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA)	Cobalamin	1 mg
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	15 mg
.alpha.-tocopherol succinate, d- (UNII: LU4B53JYVE) (.alpha.-tocopherol, d- - UNII:N9PR3490H9)	.alpha.-tocopherol, d-	30 [iU]
Selenocysteine (UNII: 0CH9049VIS) (Selenium - UNII:H6241UJ22B)	Selenium	70 ug

Ingredient Name	Strength
Inactive Ingredients
Microcrystalline Cellulose (UNII: OP1R32D61U)
Croscarmellose Sodium (UNII: M28OL1HH48)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Carob (UNII: 5MG5Z946UO)
Shellac (UNII: 46N107B71O)
Starch, Corn (UNII: O8232NY3SJ)
Calcium Stearate (UNII: 776XM7047L)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10542-014-09	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2004
2	NDC:10542-014-02	7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		02/01/2004

Labeler - Hillestad Pharmaceuticals USA (029291085)

Name	Address	ID/FEI	Business Operations
Establishment
Hillestad Pharmaceuticals USA		029291085	manufacture(10542-014) , pack(10542-014) , label(10542-014)

Revised: 10/2022

Document Id: 678d4ca4-b412-4904-8bb1-c58d54d2719b

Set id: 0bf5d3b9-5931-4180-9517-19977b58fe9a

Version: 5

Effective Time: 20221014