NDC 10542-0010-02 — Dialyvite Ascorbic Acid, Thiamine

🆔 Identity & classification

FDA NDC (as labeled) 10542-010-02

Product NDC 10542-010

11-digit billing NDC 10542001002

UNII PQ6CK8PD0R, 8K0I04919X, TLM2976OFR, 25X51I8RD4, 68Y4CF58BV, 935E97BOY8 +3 more

UPC 0105420101006

SPL Set ID 7a5e6dd6-5687-44bb-8964-841961c0e64a

Established class (EPC) Vitamin C

Chemical class Ascorbic Acid

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1988-08-01

Marketing end 2027-01-31

Route ORAL

Dosage form TABLET, COATED

Substance ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE

GPI-14 78133000000330

GPI class Dialyvite

GCN Seq No 060020

GCN 26007

HICL code 001061

Ingredient (HICL) Folic Acid/Vit B Complex And C

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 TABLET

FDB brand name Dialyvite

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

Why two NDCs? The FDA registers this code as 10542-010-02 — 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 → 10542-0010-02. 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 marketedAug 1988

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 TABLET Ingredient Folic Acid/Vit B Complex And C

🧪 What is this product?

Dialyvite is an oral tablet containing a combination of B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, and pantothenic acid), vitamin C, and biotin. These ingredients are commonly included in nutritional supplements and are typically used to help address or prevent vitamin deficiencies. This product is marketed as an unapproved drug and has not received FDA approval through a standard application process.

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.

💊 What it looks like

Color pink

ShapeRound

ImprintH

Size11 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
UNII TZ8Z31B35M
Cochineal is a natural red colorant derived from insects, used to give medicines and supplements their red or pink appearance. It helps make tablets and capsules visually identifiable.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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: 100 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 100 mg/1; 1.5 mg/1; 1.7 mg/1; 20 mg/1; 10 mg/1; 1 mg/1; 6 ug/1; 300 ug/1; 10 mgthis 10542-0010-02	Hillestad	7 tablets	—	—	FDA listed	—

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

🏛️

1988

On the market since

Aug 1988

📍

2026

Currently FDA-listed

38 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.

100 tablets10542-0010-10 6,298 Rx · $83,702

7 tablets this page10542-0010-02 No Medicaid data

Drug total (last 4 qtrs): 6,298 Rx · 204,386 units · $83,702 gross reimbursed

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

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Dialyvite — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dialyvite. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Total Part D spend

$380.28

Claims incl. refills

25

Beneficiaries

—

Spend / beneficiary

—

Spend / claim

$15.21

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Dialyvite (this brand).

Top reported reactions

Diarrhoea60

Nausea45

Renal Failure42

End Stage Renal Disease41

Chronic Kidney Disease38

Vomiting35

Death34

Age at onset

Infant1

Adolescent1

Adult49

Elderly45

Reporter sex

Male · 54%

Female · 46%

Serious outcomes

Hospitalization251

Death93

Disabling17

Life-threatening15

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
10542-0010-02 You're viewing this	7 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-010-02)	—	—	1988-08-01	Active
10542-0010-10	100 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-010-10)	$0.1629 / ea	$16.29	1988-08-01	Active

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

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 10542-0010-02?

NDC 10542-0010-02 is a 7-count package — 7 tablet, coated in 1 bottle, plastic.

What is the difference between NDC 10542-0010-02 and NDC 10542-0010-10?

Both are Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid 100 mg; 1.5 mg; 1.7 mg; 20 mg; 10 mg; 1 mg; 6 ug; 300 ug; 10 mg Tablet, Coated — the drug itself is identical. NDC 10542-0010-02 is the 7-count package, while NDC 10542-0010-10 is the 100 tablets package.

What NDC number is used to bill for this package of Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid 100 mg; 1.5 mg; 1.7 mg; 20 mg; 10 mg; 1 mg; 6 ug; 300 ug; 10 mg Tablet, Coated?

Bill NDC 10542-0010-02 — the 11-digit billing format is 10542001002. 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

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	✓ Available
Inactive ingredients (structured)	✓ 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.

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 10542-010-02, 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: 10542-0010-02, written without dashes as 10542001002. 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 10542-0010-02, the first segment (10542) is the labeler code FDA assigned to Hillestad Pharmaceuticals USA; the middle segment (0010) 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.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Hillestad Pharmaceuticals USA has reported a marketing end date of 2027-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (10542-0010-10). 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 25 words ▾

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.

⏱️ Dosage and Administration 15 words ▾

DOSAGE AND ADMINISTRATION Take one tablet per day or 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 82 words ▾

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).

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, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid NDCsSame ingredient 🏭 All Hillestad labeler NDCsLabeler code 10542 📚 All Vitamin B6 Analog NDCsDrug class

💊 Related drugs in this class

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

Multivit-Mins 25/Folic Acid/D3 10542-0009-02 Multivit-Mins No.11/Folic Acid 10542-0011-02 B Complex 11/Folic/C/Biot/Zinc 10542-0012-02 Folic Acid/B Cplx/C/Selen/Zinc 10542-0014-02 Vitamins B1,B2,B3,B5,And B6 67457-0146-30

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 Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid 100 mg; 1.5 mg; 1.7 mg; 20 mg; 10 mg; 1 mg; 6 ug; 300 ug; 10 mg Tablet, Coated, 7-count

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

💊 Medicaid utilization by pack size

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

🔬 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