Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic 100 mg; 300 ug; 10 mg; 6 ug; 1 mg; 20 mg; 10 mg; 1.7 mg; 1.5 mg; 50 mg Tablet, Coated, 100-count
by Hillestad Pharmaceuticals USA · 100 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-012-10)
NDC 10542-0012-10
🏷️ FDA NDC (as labeled)
10542-012-10
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.3686/unit — full pricing hub ↓
Also comes in:
7 tablets 10542-0012-02
Rx only
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
10542-012-10
Product NDC
10542-012
11-digit billing NDC
10542001210
NCPDP billing unit
EA — each (per item)
UNII
PQ6CK8PD0R, 8K0I04919X, TLM2976OFR, 25X51I8RD4, 68Y4CF58BV, 935E97BOY8 +4 more
UPC
0105420121004
SPL Set ID
06508e37-5ae6-4a17-bf60-b3828c6082a7
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
2002-10-01
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
GPI-14
78136000000330
GPI class
Dialyvite/Zinc
GCN Seq No
065338
GCN
23079
HICL code
036432
Ingredient (HICL)
B Complex 11/Folic/C/Biot/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 WITH ZINC TABLET
FDB brand name
Dialyvite Zinc
Legend status
Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs?
The FDA registers this code as 10542-012-10 — 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 → 10542-0012-10. 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 marketedOct 2002
Product typeHuman Prescription Drug
Portfolio5 products on file
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 WITH ZINC TABLET Ingredient B Complex 11/Folic/C/Biot/Zinc
🧪 What is this product?
Dialyvite with Zinc is a coated oral tablet containing a combination of B vitamins (thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, and pantothenic acid), vitamin C, biotin, and zinc. These ingredients are typically used as nutritional supplements to help maintain adequate levels of essential vitamins and minerals. This product is marketed without an approved FDA application and is classified as an unapproved drug.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.179 | $17.89 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3686 | $36.86 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▼ Down 2% over the last 7 months.
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 with Zinc 100 mg/1; 300 ug/1; 10 mg/1; 6 ug/1; 1 mg/1; 20 mg/1; 10 mg/1; 1.7 mg/1; 1.5 mg/1; 50 mgthis 10542-0012-10 | Hillestad | 100 tablets | $0.179 | — | 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
🏛️
2002
On the market since
Oct 2002
📍
2026
Currently FDA-listed
24 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 10542-0012-10, 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 – Q1 2026 · 5 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
378
Units reimbursed last 4 qtrs
14.4K
Gross reimbursed last 4 qtrs
$5.3K
Avg / prescription
$14.08
Avg / unit
$0.3686
Latest quarter Q1 2026
78Rx
Medicaid pays / ea
$0.3686
gross reimbursed
vs
NADAC / ea
$0.1789
acquisition cost
=
Spread
+$0.1897
+106% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 140 Rx Managed care · 238 Rx
State Medicaid map
Units reimbursed · per 100k residents
4.855.5
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 378 Rx · 14,444 units · $5,324 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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 10542-0012-02 | 7 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-012-02) | — | — | 2002-10-01 | Discontinued by firm |
| 10542-0012-10 You're viewing this | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-012-10) | $0.1789 / ea | $17.89 | 2002-10-01 | Discontinued by firm |
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 10542-0012-10?
NDC 10542-0012-10 is a 100-count package — 100 tablet, coated in 1 bottle, plastic.
What is the difference between NDC 10542-0012-10 and NDC 10542-0012-02?
Both are Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic 100 mg; 300 ug; 10 mg; 6 ug; 1 mg; 20 mg; 10 mg; 1.7 mg; 1.5 mg; 50 mg Tablet, Coated — the drug itself is identical. NDC 10542-0012-10 is the 100-count package, while NDC 10542-0012-02 is the 7 tablets package.
What NDC number is used to bill for this package of Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic 100 mg; 300 ug; 10 mg; 6 ug; 1 mg; 20 mg; 10 mg; 1.7 mg; 1.5 mg; 50 mg Tablet, Coated?
Bill NDC 10542-0012-10 — the 11-digit billing format is 10542001210. 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) | ✓ Available |
| 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.
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 10542-012-10, 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: 10542-0012-10, written without dashes as 10542001210. 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 10542-0012-10, the first segment (10542) is the labeler code FDA assigned to Hillestad Pharmaceuticals USA; the middle segment (0012) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 7 tablets (10542-0012-02). 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 ▾
INDICATIONS AND USAGE Dialyvite with Zinc is a prescription folic acid supplement with Zinc and additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Take one tablet per day or as directed by your physician, orally.
⛔ Contraindications ▾
CONTRAINDICATIONS This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.
📋 Description ▾
DESCRIPTION Dialyvite with Zinc is a prescription folic acid supplement with zinc and additional nutrients for kidney dialysis patients. Dialyvite with Zinc is a small, round, yellow, 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 Zinc (Zinc Citrate).....50 mg Inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Calcium Stearate.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.