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NDC 10542-0010-02 Dialyvite 100; 300; 10; 6; 1; 20; 10; 1.7; 1.5 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

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

Dialyvite 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.

Product Information

NDC	10542-0010
Product ID	10542-010_5f304b64-cc7c-4744-853e-5341055612a3
Associated GPIs	78133000000330
GCN Sequence Number	060020
GCN Sequence Number Description	folic acid/vit B complex and C TABLET 1 MG-100MG ORAL
HIC3	C6B
HIC3 Description	VITAMIN B PREPARATIONS
GCN	26007
HICL Sequence Number	001061
HICL Sequence Number Description	FOLIC ACID/VITAMIN B COMPLEX AND VITAMIN C
Brand/Generic	Brand
Proprietary Name	Dialyvite
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid
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
Active Ingredient Units	mg/1; ug/1; mg/1; ug/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
Labeler Name	Hillestad Pharmaceuticals USA
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], 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 10542-0010-02 (10542001002)

Pricing Information	N/A
NDC Package Code	10542-010-02
Billing NDC	10542001002
Package	7 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-010-02)
Marketing Start Date	1988-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7a5e6dd6-5687-44bb-8964-841961c0e64a Details

DESCRIPTION

Dialyvite is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite is a small, round, light pink, 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

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color).

INDICATIONS AND USAGE

Dialyvite 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 as directed by your physician, orally.

PRINCIPAL DISPLAY PANEL

NDC 10542-010-10

Dialyvite

Multivitamin Supplement for Dialysis Patients

100 Tablets

INGREDIENTS AND APPEARANCE

DIALYVITE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:10542-010
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

Ingredient Name	Strength
Inactive Ingredients
Microcrystalline Cellulose (UNII: OP1R32D61U)
Croscarmellose Sodium (UNII: M28OL1HH48)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Starch, Corn (UNII: O8232NY3SJ)
Hypromellose, unspecified (UNII: 3NXW29V3WO)
Polyethylene Glycol, unspecified (UNII: 3WJQ0SDW1A)
Calcium Stearate (UNII: 776XM7047L)
Cochineal (UNII: TZ8Z31B35M)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10542-010-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/1988
2	NDC:10542-010-02	7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/1988

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		08/01/1988

Labeler - Hillestad Pharmaceuticals USA (029291085)

Name	Address	ID/FEI	Business Operations
Establishment
Hillestad Pharmaceuticals USA		029291085	manufacture(10542-010) , pack(10542-010) , label(10542-010)

Revised: 10/2022

Document Id: 5f304b64-cc7c-4744-853e-5341055612a3

Set id: 7a5e6dd6-5687-44bb-8964-841961c0e64a

Version: 4

Effective Time: 20221014