NDC 10542-0014-02 — Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid

🆔 Identity & classification

FDA NDC (as labeled) 10542-014-02

Product NDC 10542-014

11-digit billing NDC 10542001402

UNII PQ6CK8PD0R, 8K0I04919X, TLM2976OFR, 25X51I8RD4, 68Y4CF58BV, 935E97BOY8 +6 more

UPC 0105420140906

SPL Set ID 0bf5d3b9-5931-4180-9517-19977b58fe9a

Established class (EPC) Vitamin C

Chemical class Ascorbic Acid

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Jul 2026)

Marketing start 2004-02-01

Marketing end 2026-07-31

Route ORAL

Dosage form TABLET, COATED

Substance ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; ZINC CITRATE; .ALPHA.-TOCOPHEROL SUCCINATE, D-; SELENOCYSTEINE

GPI-14 78137000000330

GPI class Dialyvite 3000

GCN Seq No 054647

GCN 22637

HICL code 026342

Ingredient (HICL) Folic Acid/B Cplx/C/Selen/Zinc

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C6

Therapeutic class — intermediate (HIC2) Vitamins

HIC3 code C6B

Therapeutic class — specific (HIC3) Vitamin B Preparations

AHFS code 88:08.00.00

AHFS class Vitamin B Complex

FDB label name DIALYVITE 3,000 TABLET

FDB brand name Dialyvite 3000

Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation

Why two NDCs? The FDA registers this code as 10542-014-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 10542-0014-02. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerHillestad Pharmaceuticals USA

Labeler code10542

First marketedFeb 2004

Product typeHuman Prescription Drug

Portfolio5 products on file

🔎 All NDCs from Hillestad Pharmaceuticals USA

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DIALYVITE 3,000 TABLET Ingredient Folic Acid/B Cplx/C/Selen/Zinc

🧪 What is this product?

Dialyvite 3000 is a coated oral tablet containing a combination of B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, and biotin), vitamin C, vitamin E, pantothenic acid, zinc, and selenium. These ingredients are commonly used together in nutritional supplements, particularly for patients with kidney disease or those undergoing dialysis, to help address nutrient losses and support overall nutrition. This product is marketed without an FDA-approved application.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 90 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dialyvite 3000 30 [iU]/1; 100 mg/1; 300 ug/1; 10 mg/1; 1 mg/1; 3 mg/1; 20 mg/1; 25 mg/1; 1.7 mg/1; 70 ugthis 10542-0014-02	Hillestad	7 tablets	—	—	Discontinued	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2004

On the market since

Feb 2004

📍

2026

Currently FDA-listed

22 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

90 tablets10542-0014-09 60 Rx · $1,099

7 tablets this page10542-0014-02 No Medicaid data

Drug total (last 4 qtrs): 60 Rx · 2,129 units · $1,099 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium — the ingredient across all brands.

Top reported reactions

Diarrhoea6

Dialysis5

Hospitalisation5

Pneumonia5

Cardiac Disorder3

Death3

Dyspnoea3

Age at onset

Adult3

Elderly6

Reporter sex

Male · 45%

Female · 55%

Serious outcomes

Hospitalization19

Death5

Life-threatening3

Disabling1

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
10542-0014-02 You're viewing this	7 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-014-02)	—	—	2004-02-01	Discontinued by firm
10542-0014-09	90 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-014-09)	$0.2855 / ea	$25.69	2004-02-01	Discontinued by firm

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 10542-0014-02?

NDC 10542-0014-02 is a 7-count package — 7 tablet, coated in 1 bottle, plastic.

What is the difference between NDC 10542-0014-02 and NDC 10542-0014-09?

Both are Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium 30 [iU]/1; 100 mg; 300 ug; 10 mg; 1 mg; 3 mg; 20 mg; 25 mg; 1.7 mg; 70 ug Tablet, Coated — the drug itself is identical. NDC 10542-0014-02 is the 7-count package, while NDC 10542-0014-09 is the 90 tablets package.

What NDC number is used to bill for this package of Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium 30 [iU]/1; 100 mg; 300 ug; 10 mg; 1 mg; 3 mg; 20 mg; 25 mg; 1.7 mg; 70 ug Tablet, Coated?

Bill NDC 10542-0014-02 — the 11-digit billing format is 10542001402. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 10542-014-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 10542-0014-02, written without dashes as 10542001402. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 10542-0014-02, the first segment (10542) is the labeler code FDA assigned to Hillestad Pharmaceuticals USA; the middle segment (0014) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (10542-0014-09). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Hillestad Pharmaceuticals USA is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 📋 Description

🎯 Indications and Usage 26 words ▾

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.

⏱️ Dosage and Administration 16 words ▾

DOSAGE AND ADMINISTRATION Take one tablet per day or use as directed by your physician, orally.

⛔ Contraindications 15 words ▾

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

🤒 Adverse Reactions 22 words ▾

ADVERSE REACTIONS Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

📋 Description 101 words ▾

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium NDCsSame ingredient 🏭 All Hillestad labeler NDCsLabeler code 10542 📚 All Copper Absorption Inhibitor NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Vitamin B Preparations.

Folic Acid/Vit B Complex And C 10542-0010-02 Multivit-Mins No.11/Folic Acid 10542-0011-02 B Complex 11/Folic/C/Biot/Zinc 10542-0012-02

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium 30 [iU]/1; 100 mg; 300 ug; 10 mg; 1 mg; 3 mg; 20 mg; 25 mg; 1.7 mg; 70 ug Tablet, Coated, 7-count

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

💊 Medicaid utilization by pack size

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class