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, 100-count — NDC 10542-0010-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

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, 100-count — NDC 10542-010-10 (Billing 10542-0010-10)

by Hillestad Pharmaceuticals USA · 100 TABLET, COATED in 1 BOTTLE, PLASTIC

This is a package of 100 tablets 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 from Hillestad Pharmaceuticals USA, marketed since Aug 1988 and currently FDA-listed, this package's marketing is listed to end Jan 2027; retail pharmacies pay about $0.1624 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 10542-0010-10
🏷️ FDA NDC (as labeled) 10542-010-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1624 NADAC Per package$16.24 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4063/unit — full pricing hub ↓
Main listing for product 10542-010 · Also comes in: 7 tablets 10542-010-02
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 10542-010-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
10542 labeler · 010 product · 10 package
Package marketed since
Aug 1, 1988
Package marketing ended
Jan 31, 2027
Sample package
No — commercial package
Billing quantity
100 EA per package
Barcode (UPC)
0105420101006
Medicaid fills, this package
6,106 prescriptions in the last four reported quarters
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10542-010-10
Product NDC 10542-010
11-digit billing NDC 10542001010
NCPDP billing unit EA — each (per item)
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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 060020
  • GCN: 26007
  • GPI-14 (Medi-Span): 78133000000330
  • HICL (First Databank): 001061
  • AHFS class code: 88:08.00.00
Why two NDCs? The FDA registers this code as 10542-010-10 — 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 → 10542-0010-10. 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.

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.

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.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.162 $16.24 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.4063 $40.63 / 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
Jul 2021 Nov 2022 Mar 2026 Sep 2026 $0.171 $0.132
▲ Up 23% over the last 18 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
10542-0010-02 10542-010-02 7 TABLET, COATED in 1 BOTTLE, PLASTIC Sample — — 1988-08-01 Jan 31, 2027 Active
10542-0010-10 You're viewing this Main listing 100 TABLET, COATED in 1 BOTTLE, PLASTIC $0.1624 / ea $16.24 1988-08-01 Jan 31, 2027 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 this package?
This is a 100-count package — 100 tablet, coated in 1 bottle, plastic.
How does this package differ from NDC 10542-0010-02?
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. This page's package is the 100-count one, while NDC 10542-0010-02 is the 7 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?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 10542-0010-10 Hillestad 100 tablets $0.162 — Availability likely —
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.

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.

Manufacturer & labeler

LabelerHillestad Pharmaceuticals USA
Labeler code10542
First marketedAug 1988
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.

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 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).

⚠️ Precautions 24 words ▾

PRECAUTIONS Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress. Keep out of reach of children.

📄 Package Label / Principal Display Panel 15 words ▾

PRINCIPAL DISPLAY PANEL NDC 10542-010-10 Dialyvite Multivitamin Supplement for Dialysis Patients 100 Tablets Dialyvite PDP

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

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 this package alone, 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
6.1K
Units reimbursed last 4 qtrs
199.4K
Gross reimbursed last 4 qtrs
$81K
Avg / prescription
$13.27
Avg / unit
$0.4063
Latest quarter Q1 2026
1.1KRx
Medicaid pays / ea
$0.4063
gross reimbursed
vs
NADAC / ea
$0.1624
acquisition cost
=
Spread
+$0.2439
+150% 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 ⓘ
35% FFS 65% MCO
Fee-for-service · 2,166 Rx Managed care · 3,940 Rx
State Medicaid map
Alaska: no data reported AK Maine: 5,234 units · 375 per 100k residents ME Washington: 21,023 units · 269 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 69,210 units · 1,206 per 100k residents MN Wisconsin: no data reported WI Michigan: 11,575 units · 115 per 100k residents MI New York: 10,425 units · 53.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 6,038 units · 143 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,618 units · 12.9 per 100k residents IL Indiana: 1,118 units · 16.3 per 100k residents IN Ohio: 17,671 units · 150 per 100k residents OH Pennsylvania: 4,640 units · 35.8 per 100k residents PA New Jersey: 21,630 units · 233 per 100k residents NJ Massachusetts: no data reported MA California: 353 units · 0.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 458 units · 23.2 per 100k residents NE Missouri: 15,710 units · 254 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,267 units · 14.5 per 100k residents VA Maryland: 540 units · 8.7 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 1,779 units · 33.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 1,718 units · 33.6 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 4,280 units · 14.0 per 100k residents TX Florida: 3,138 units · 13.9 per 100k residents FL
Units reimbursed · per 100k residents
0.91,206
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 Minnesota 1,206 /100k
2 Maine 375 /100k
3 Washington 269 /100k
4 Missouri 254 /100k
5 New Jersey 233 /100k
6 Ohio 150 /100k
7 Oregon 143 /100k
8 Michigan 115 /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.
7 tablets10542-0010-02 No Medicaid data
Drug total (last 4 qtrs): 6,106 Rx · 199,425 units · $81,017 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.

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) ✓ 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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 7 tablets (10542-0010-02). 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.
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.