NDC 10542-0011-09 — Dialyvite 5000 Ascorbic Acid, Tocopheryl Acid

🆔 Identity & classification

FDA NDC (as labeled) 10542-011-09

Product NDC 10542-011

11-digit billing NDC 10542001109

NCPDP billing unit EA — each (per item)

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

UPC 0105420110909

SPL Set ID 97791f73-e0c5-45a6-8aed-f456a5466eaf

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 2008-05-01

Marketing end 2027-02-28

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 78137000000340

GPI class Dialyvite 5000

GCN Seq No 064280

GCN 99986

HICL code 035761

Ingredient (HICL) Multivit-Mins No.11/Folic Acid

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 5000 TABLET

FDB brand name Dialyvite 5000

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

Why two NDCs? The FDA registers this code as 10542-011-09 — 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 → 10542-0011-09. 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 marketedMay 2008

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 5000 TABLET Ingredient Multivit-Mins No.11/Folic Acid

🧪 What is this product?

Dialyvite 5000 is a coated tablet taken by mouth that contains a combination of vitamins and minerals. The product includes vitamin C, B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, and biotin), pantothenic acid, vitamin E, and the minerals zinc and selenium. These ingredients are commonly used in nutritional supplements, particularly for patients with kidney disease who may have nutrient losses or deficiencies. This product is marketed without an approved FDA 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.

💊 What it looks like

Color purple

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 253RUG1X1A
A natural flavoring and coloring agent derived from blueberry fruit. It adds taste and blue-purple color to the medicine while serving no therapeutic purpose.
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 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 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 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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	$0.6329	$56.96 / 90 tablets
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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 5000 100 mg/1; 1.5 mg/1; 1.7 mg/1; 20 mg/1; 50 mg/1; 5 mg/1; 2 mg/1; 300 ug/1; 10 mg/1; 25 mgthis 10542-0011-09	Hillestad	90 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

🏛️

2008

On the market since

May 2008

📍

2026

Currently FDA-listed

18 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 10542-0011-09, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

229

Units reimbursed last 4 qtrs

9.6K

Gross reimbursed last 4 qtrs

$6.1K

Avg / prescription

$26.59

Avg / unit

$0.6329

Latest quarter Q4 2025

53Rx

Fee-for-service vs managed care ⓘ

12% FFS 88% MCO

Fee-for-service · 27 Rx Managed care · 202 Rx

State Medicaid map

Units reimbursed · per 100k residents

34.552.3

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Ohio 52.3 /100k

2 Michigan 34.5 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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 tablets this page10542-0011-09 229 Rx · $6,088

7 tablets10542-0011-02 No Medicaid data

Drug total (last 4 qtrs): 229 Rx · 9,620 units · $6,088 gross reimbursed

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

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
10542-0011-02	7 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-011-02)	2008-05-01	Active
10542-0011-09 You're viewing this	90 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-011-09)	2008-05-01	Active

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

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 10542-0011-09?

NDC 10542-0011-09 is a 90-count package — 90 tablet, coated in 1 bottle, plastic.

What is the difference between NDC 10542-0011-09 and NDC 10542-0011-02?

Both are Dialyvite 5000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium 100 mg; 1.5 mg; 1.7 mg; 20 mg; 50 mg; 5 mg; 2 mg; 300 ug; 10 mg; 25 mg Tablet, Coated — the drug itself is identical. NDC 10542-0011-09 is the 90-count package, while NDC 10542-0011-02 is the 7 tablets package.

What NDC number is used to bill for this package of Dialyvite 5000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium 100 mg; 1.5 mg; 1.7 mg; 20 mg; 50 mg; 5 mg; 2 mg; 300 ug; 10 mg; 25 mg Tablet, Coated?

Bill NDC 10542-0011-09 — the 11-digit billing format is 10542001109. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ Available

“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 10542-011-09, 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: 10542-0011-09, written without dashes as 10542001109. 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 10542-0011-09, the first segment (10542) is the labeler code FDA assigned to Hillestad Pharmaceuticals USA; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 2027-02-28, 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 7 tablets (10542-0011-02). 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 5000 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 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.

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 B Complex 11/Folic/C/Biot/Zinc 10542-0012-02 Folic Acid/B Cplx/C/Selen/Zinc 10542-0014-02

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 5000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium 100 mg; 1.5 mg; 1.7 mg; 20 mg; 50 mg; 5 mg; 2 mg; 300 ug; 10 mg; 25 mg Tablet, Coated, 90-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 & spend

💊 Medicaid utilization by pack size

📦 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