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NDC 10542-0011-09 Dialyvite 5000 30; 100; 300; 10; 2; 5; 20; 50; 1.7; 70; 1.5; 25 [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 5000 30; 100; 300; 10; 2; 5; 20; 50; 1.7; 70; 1.5; 25 [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 5000 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	10542-0011
Product ID	10542-011_88e23f86-93fa-4b8e-9804-c714f539727e
Associated GPIs	78137000000340
GCN Sequence Number	064280
GCN Sequence Number Description	multivit-mins no.11/folic acid TABLET 5 MG ORAL
HIC3	C6B
HIC3 Description	VITAMIN B PREPARATIONS
GCN	99986
HICL Sequence Number	035761
HICL Sequence Number Description	MULTIVITAMINS WITH MINERALS NO.11/FOLIC ACID
Brand/Generic	Brand
Proprietary Name	Dialyvite 5000
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; 2; 5; 20; 50; 1.7; 70; 1.5; 25
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 10542-0011-09 (10542001109)

Pricing Information	N/A
NDC Package Code	10542-011-09
Billing NDC	10542001109
Package	90 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-011-09)
Marketing Start Date	2008-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 97791f73-e0c5-45a6-8aed-f456a5466eaf Details

DESCRIPTION

Dialyvite 5000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite 5000 is a small, round, purple, coated tablet, with debossed "H" on one side.

Each tablet contains:

Folic Acid.....5 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).....50 mg

Vitamin B12 (Methylcobalamin).....2 mg

Biotin.....300 mcg

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

Zinc (Zinc Citrate).....25 mg

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

Inactive ingredients:

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

INDICATIONS AND USAGE

Dialyvite 5000 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 10542-011-09

Dialyvite 5000

Multivitamin Supplement for Dialysis Patients

90 Tablets

INGREDIENTS AND APPEARANCE

DIALYVITE 5000

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:10542-011
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	50 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	5 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA)	Cobalamin	2 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	25 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)
Shellac (UNII: 46N107B71O)
Starch, Corn (UNII: O8232NY3SJ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Blueberry (UNII: 253RUG1X1A)
Calcium Stearate (UNII: 776XM7047L)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10542-011-09	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2008
2	NDC:10542-011-02	7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		05/01/2008

Labeler - Hillestad Pharmaceuticals USA (029291085)

Name	Address	ID/FEI	Business Operations
Establishment
Hillestad Pharmaceuticals USA		029291085	manufacture(10542-011) , pack(10542-011) , label(10542-011)

Revised: 10/2022

Document Id: 88e23f86-93fa-4b8e-9804-c714f539727e

Set id: 97791f73-e0c5-45a6-8aed-f456a5466eaf

Version: 4

Effective Time: 20221014