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Multivitamin with Fluoride Sodium .25 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable, 100-count — NDC 75826-0169-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Multivitamin with Fluoride Sodium .25 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable, 100-count — NDC 75826-169-10 (Billing 75826-0169-10)

by WINDER LABORATORIES, LLC · 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Multivitamin with Fluoride Sodium .25 mg; 750 ug; 24 mg; 36 mg; 10 ug; 6.75 mg; 1.05 mg; 1.2 mg; 13.5 mg Tablet, Chewable from WINDER LABORATORIES, LLC, marketed since Dec 2023 and currently FDA-listed, this package's marketing is listed to end Jun 2027. It is this product's only package size.

NDC 75826-0169-10
🏷️ FDA NDC (as labeled) 75826-169-10 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 75826-169-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
75826 labeler · 169 product · 10 package
Package marketed since
Feb 1, 2024
Package marketing ended
Jun 30, 2027
Sample package
No — commercial package
Barcode (UPC)
0375826169102, 0375826170108, 0375826171105
Medicaid fills, this package
468 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 75826-169-10
Product NDC 75826-169
11-digit billing NDC 75826016910
UNII WR1WPI7EW8, 68Y4CF58BV, 81G40H8B0T, 8K0I04919X, 1C6V77QF41, 25X51I8RD4 +6 more
UPC 0375826169102, 0375826170108, 0375826171105
SPL Set ID a10ff759-eba7-414b-bb98-f17fbb6e6b57
Established class (EPC) Vitamin A; Vitamin D; Vitamin B12; Vitamin C
Chemical class Vitamin A; Vitamin D; Vitamin B 12; Ascorbic Acid
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-01
Marketing end 2027-06-30
Route ORAL
Dosage form TABLET, CHEWABLE
Substance SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN

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

GPI-14 78441000000505
GCN Seq No 085637
GCN 55154
HICL code 049357
Ingredient (HICL) Pedi Multivit No.242/Fluoride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6H
Therapeutic class — specific (HIC3) Pediatric Vitamin Preparations
AHFS code 88:28.00.00
AHFS class Multivitamin Preparations
FDB label name MULTIVIT-FLUOR 0.25 MG TAB CHW
FDB brand name Multivitamin With Fluoride
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 085637
  • GCN: 55154
  • GPI-14 (Medi-Span): 78441000000505
  • HICL (First Databank): 049357
  • AHFS class code: 88:28.00.00
Why two NDCs? The FDA registers this code as 75826-169-10 — 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 → 75826-0169-10. 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 MULTIVIT-FLUOR 0.25 MG TAB CHW Ingredient Pedi Multivit No.242/Fluoride
🧪 What is this product?

This is a chewable tablet containing multiple vitamins and sodium fluoride taken by mouth. The product includes vitamins A, C, D, and B-complex vitamins (B1, B2, B3, B6, and B12) along with folic acid, which are typically used as nutritional supplements to help maintain adequate vitamin intake. Sodium fluoride is commonly added to such products for dental health support. This product is marketed without an FDA-approved application.

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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.1318 $13.18 / 100 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
75826-0169-10 You're viewing this Main listing 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2023-12-01 Jun 30, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Multivitamin with Fluoride .25 mg/1; 750 ug/1; 24 mg/1; 36 mg/1; 10 ug/1; 6.75 mg/1; 1.05 mg/1; 1.2 mg/1; 13.5 mgthis 75826-0169-10 WINDER 100 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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 red / pink / purple
ShapeRound
ImprintWL171
Size13 mm
ScoringNot scored
FlavorGrape
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 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 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

7 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

LabelerWINDER LABORATORIES, LLC
Labeler code75826
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from WINDER LABORATORIES, LLC labeler code 75826

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 ⏱️ Dosage and Administration ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Supplementation of the diet with fluoride and ten essential vitamins. Multivitamin with 1.0 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm. Multivitamin with 0.5 mg Fluoride Chewable Tablet s provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Multivitamin with 0.25 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride Chewable Tablets supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

Supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Children using Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations.

The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable tablets are prescription product for the clinical dietary management of metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

⏱️ Dosage and Administration 9 words ▾

DOSAGE AND ADMINISTRATION One tablet daily or as prescribed.

⚠️ Warnings 170 words ▾

WARNING Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Keep this and all medication out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately. CAUTION Should be chewed. This product, as with all chewable tablets, is not recommended for children under age 4 due to risk of choking.

Do not eat or drink dairy products within one hour of fluoride administration. PRECAUTIONS The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Before prescribing Multivitamin with Fluoride Chewable Tablets: Determine the fluoride content of the drinking water from all major sources.

Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. Periodically check to make sure that the child does not develop significant dental fluorosis.

🤒 Adverse Reactions 11 words ▾

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.

🧬 Clinical Pharmacology 197 words ▾

CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Multivitamin with Fluoride Chewable Tabletsprovide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation: Ca 10 (PO 4) 6(OH) 2+ 2F -------› Ca 10(PO 4)F 2+ 2OH - (Hydroxyapatite) (Fluorapatite) (Hydroxyapatite) (Fluorapatite) Three stages of fluoride deposition in tooth enamel can be distinguished: Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

📦 How Supplied / Storage and Handling 180 words ▾

HOW SUPPLIED 3.25 mg: Multivitamin chewable tablets containing 0.25 mg fluoride are pink-colored, grape flavor, un-scored, round tablet, debossed with “WL” “169” on one side and plain on other side of tablet. Available in bottle of 100 (NDC 75826-169-10). 0.5 mg: Multivitamin chewable tablets containing 0.5 mg fluoride are peach-colored, grape flavor, un-scored, round tablet, debossed with “WL” “170” on one side and plain on other side of tablet.

Available in bottle of 100 (NDC 75826-170-10). 1.0 mg: Multivitamin chewable tablets containing 1.0 mg fluoride are purple-colored, grape flavor, un-scored, round tablet, debossed with “WL” “171” on one side and plain on other side of tablet. Available in bottle of 100 (NDC 75826-171-10).

STORAGE Store at 20° - 25°C (68°-77°F); excursions permitted to 15° - 30°C (59°-86°F). See USP Controlled Room Temperature. Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. Manufactured by: Winder Laboratories LLC Winder GA, 30680 RLS.170.99-3.0 Rev: 01/2024

📋 Description 65 words ▾

Rx Only * Daily Value (% DV) not established Active ingredients: Fluoride as sodium fluoride. Other Ingredients: Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid, Sucrose. 0.25 mg also contains: D&C Red #27 Alum Lake and FD&C Yellow #6 Alum Lake. 0.5 mg also contains: FD&C Red #40 Alum Lake. 1.0 mg also contains: D&C Red #27 and FD&C Blue #1. Nutrition Fact

📄 Package Label / Principal Display Panel 30 words ▾

Package/Label Display Panel Multivitamin with Fluoride Chewable Tablets 0.25 mg 100 count Multivitamin with Fluoride Chewable Tablets 0.5 mg 100 count Multivitamin with Fluoride Chewable Tablets 1.0 mg 100 count

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
468
Units reimbursed last 4 qtrs
17.6K
Gross reimbursed last 4 qtrs
$2.3K
Avg / prescription
$4.95
Avg / unit
$0.1318
Latest quarter Q1 2026
25Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 468 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 2,690 units · 20.8 per 100k residents PA New Jersey: 9,520 units · 102 per 100k residents NJ Massachusetts: 1,000 units · 14.3 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported 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: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 4,356 units · 304 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
14.3304
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 Hawaii 304 /100k
2 New Jersey 102 /100k
3 Pennsylvania 20.8 /100k
4 Massachusetts 14.3 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Multivitamin With Fluoride — 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 Multivitamin With Fluoride. 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.
Period
Total Part D spend
$343.82
Claims incl. refills
57
Beneficiaries
23
Spend / beneficiary
$14.95
Spend / claim
$6.03
Trend by period
💵 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) — 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 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 WINDER LABORATORIES, LLC has reported a marketing end date of 2027-06-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
WINDER LABORATORIES, LLC 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.
← 75826-0165-20 · WINDER 75826-0170-10 · WINDER →
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.