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IOSAT Potassium Iodide 65 mg Tablet, 14-count — NDC 51803-0002-02 package photo

IOSAT Potassium Iodide 65 mg Tablet, 14-count

by Anbex Inc. · 14 TABLET in 1 PACKAGE (51803-002-02)
NDC 51803-0002-02
🏷️ FDA NDC (as labeled) 51803-002-02 billing pads the product segment with a zero
This package
Contains14-count Pack sizes2 compare ↓
Also comes in: 20 tablets 51803-0002-01
OTC Brand On market Non-controlled
🗂️ 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 51803-002-02
Product NDC 51803-002
11-digit billing NDC 51803000202
RxCUI 430174, 1423814
UNII 1C4QK22F9J
Application # NDA018664
SPL Set ID bab815ee-47ef-4c87-a60d-e0d7863ad871
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-05-01
Route ORAL
Dosage form TABLET
Substance POTASSIUM IODIDE
GPI-14 93000065100305
GCN Seq No 052900
GCN 20175
HICL code 000748
Ingredient (HICL) Potassium Iodide
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3H
Therapeutic class — specific (HIC3) Iodine Containing Agents
AHFS code 08:14.92.00
AHFS class Antifungals, Miscellaneous
FDB label name IOSAT 65 MG TABLET
FDB brand name Iosat
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 51803-002-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51803-0002-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Expectorants class.

Drug family (ATC) Expectorants, Other ophthalmologicals, Antidotes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAnbex Inc.
Application holderANBEX INC
FDA applicationNDA018664 (NDA)
Labeler code51803
First marketedMay 2013
Product typeHuman Otc Drug
Portfolio2 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 IOSAT 65 MG TABLET Ingredient Potassium Iodide
📖 What it is MedlinePlus · NLM

Potassium iodide is used to protect the thyroid gland from taking in radioactive iodine that may be released during a nuclear radiation emergency. Radioactive iodine can damage the thyroid gland. You should only take potassium iodide if there is a nuclear radiation emergency and public officials tell you that you should take it. Potassium iodide is in a class of medications called anti-thyroid medications. It works by blocking radioactive iodine from entering the thyroid gland. Potassium iodide can protect you from the effects of radioactive iodine that may be released during a nuclear radiati...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's reasonable to have it on hand if public health authorities in your area recommend it — especially if you live near a nuclear facility. But the key rule is: only take it when p...
  • Should I keep potassium iodide at home just in case, or only take it if there's actually an emergency?
  • No — taking more than one dose every 24 hours will not give you more protection. Your thyroid can only hold a certain amount of iodine at a time, so once it's full, extra doses jus...
  • What if I take an extra dose? Will it protect me better?
📖 Read our full Potassium Iodide guide →
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 white
ShapeRound
ImprintIOSAT
Size5 mm
ScoringScored — splits in 4
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 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 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 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 L0IYT1O31N
    A salt derived from sulfur compounds, sodium thiosulfate serves as a buffer and stabilizer in medicines. It helps maintain the product's pH balance and chemical stability.

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

The official label also statesmagnesium stearate, microcrystalline cellulose, silica gel, sodium thiosulfate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ThyroSafe 65 mg 50633-0910-20 BTG 3200 tablets — — FDA listed —
Iosat 65 mgthis 51803-0002-02 Anbex 14 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2013
On the market since
May 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for IOSAT (this brand).

Top reported reactions

Diarrhoea273
Haemorrhagic Stroke254
Sepsis254
Dyspnoea252
Fatigue247
Fall243
Headache241

Reporter sex

0 reports

Serious outcomes

Death381
Disabling20
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 263 29
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51803-0002-01 20 TABLET in 1 PACKAGE (51803-002-01) 2013-05-01 Active
51803-0002-02 You're viewing this 14 TABLET in 1 PACKAGE (51803-002-02) 2015-11-23 Active

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

Pack size FAQ

What quantity is in NDC 51803-0002-02?
NDC 51803-0002-02 is a 14-count package — 14 tablet in 1 package.
What is the difference between NDC 51803-0002-02 and NDC 51803-0002-01?
Both are IOSAT Potassium Iodide 65 mg Tablet — the drug itself is identical. NDC 51803-0002-02 is the 14-count package, while NDC 51803-0002-01 is the 20 tablets package.
What NDC number is used to bill for this package of IOSAT Potassium Iodide 65 mg Tablet?
Bill NDC 51803-0002-02 — the 11-digit billing format is 51803000202. 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

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 51803-002-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51803-0002-02, written without dashes as 51803000202. 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 51803-0002-02, the first segment (51803) is the labeler code FDA assigned to Anbex Inc.; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Anbex Inc.. Listing status can change — 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 20 tablets (51803-0002-01). 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?
Anbex Inc. 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description
🎯 Indications and Usage 46 words ▾

Uses Helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency. Use along with other emergency measures recommended by public officials.

INDICATIONS IOSAT™ (Potassium Iodide tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

⏱️ Dosage and Administration 214 words ▾

Directions use as directed by public officials in the event of a nuclear radiation emergency do not take more than 1 dose in 24 hours tablets can be whole or crushed and mixed in milk, baby formula, water, orange juice, flat soda like cola, or raspberry syrup The liquid mixture should be given to infants, young children, and others who cannot swallow tablets; see consumer package insert on how to make a liquid mixture. Age Dose Adults over 18 years 2 tablets (whole or crushed) daily (130 mg) Children over 12 years to 18 years who weigh at least 150 pounds 2 tablets (whole or crushed) daily (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) daily (65 mg) Children over 3 years to 12 years 1 tablet (whole or crushed) daily (65 mg) Children over 1 month to 3 years 1/2 tablet (crushed) 32.5 mg daily as directed in the consumer package insert Birth to 1 month 16.25 mg daily as directed in the consumer package insert If pregnant, breastfeeding, have a baby up to 1 month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact a doctor as soon as possible.

⚠️ Warnings ~3 min read ▾

Warnings Allergy alert: Iodine may cause an allergic reaction with 1 or more of the following symptoms: shortness of breath or wheezing swelling skin rash trouble breathing, speaking or swallowing fever and joint pain Do not use if you have ever had an allergic reaction to iodine nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis Stop use and ask a doctor if you have an allergic reaction. Get medical help right away if you have trouble breathing, speaking or swallowing; shortness of breath; wheezing; swelling of the mouth, tongue or throat; or rash. irregular heartbeat or chest pain.

Get medical help right away. swelling of the hands or feet, fever, or joint pain. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

WARNING People who are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease should not take KI. Keep out of the reach of children. In case of an allergic reaction (difficulty breathing, speaking or swallowing; wheezing; shortness of breath or swelling of the mouth or throat), call 911 or get medical care right away.

In case of overdose, get medical help or call a Poison Control Center right away. HOW POTASSIUM IODIDE WORKS Certain forms of iodine help your thyroid gland work right. Most people get the iodine they need from foods like iodized salt or fish.

The thyroid can “store” or hold only a certain amount of iodine. In nuclear radiation emergency, radioactive iodine may be released in the air. This material may be breathed or swallowed.

It may enter the thyroid gland and damage it. The damage would probably not show itself for years. Children are most likely to have thyroid damage.

If you take KI, it will block or reduce the chances that radioactive iodine will enter your thyroid gland. WHO SHOULD NOT TAKE POTASSIUM IODIDE People should avoid KI if they are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease, because these conditions may increase the chances of side effects to iodine. HOW AND WHEN TO TAKE POTASSIUM IODIDE KI should be taken as soon as possible after public officials tell you.

If you are told to repeat the dose, you should take the second dose 24 hours after the first dose. Do not take it sooner. More KI will not help you because the thyroid can “hold” only certain amounts of iodine.

Taking more than 1 dose per day will increase the chances of side effects. The public officials will tell you how many days to take KI. You should take KI until the chances of major exposure to radioactive iodine by breathing or swallowing stops.

SIDE EFFECTS Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you are told. Possible side effects include: swelling of the salivary glands, nausea, vomiting, diarrhea, stomach ache, fever, headache, metallic taste, and allergic reactions.

Allergic reaction can include skin rashes such as hives swelling of various parts of the body such as the face, lips, tongue, throat, hands or feet fever with joint pain trouble breathing, speaking or swallowing wheezing or shortness of breath Get medical attention right away if you have trouble breathing, speaking or swallowing; wheezing; shortness of breath; or swelling of the mouth, tongue or throat. Taking iodide, in rare cases, may cause overactivity of the thyroid gland, underactivity of the thyroid gland, or enlargement of the thyroid gland (goiter).

Symptoms of an overactive thyroid gland may include an irregular heartbeat and chest pain. Patients with thyroid disease are more likely to get these side effects. Babies under 1 month of age are more likely to get an underactive thyroid gland (hypothyroidism).

WHAT TO DO IF SIDE EFFECTS OCCUR Stop taking KI and call a doctor if you have one of the following symptoms…

📦 How Supplied / Storage and Handling 129 words ▾

HOW SUPPLIED IOSAT™ (Potassium Iodide Tablets, USP 65 mg) Packages of 20 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide. NDC 51803-002-01: 2 X 10 Unit dose, Foil Sealed, 65 mg Tablets (20 Tablets).

IOSAT™ (Potassium Iodide Tablets, USP 65 mg) Packages of 14 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide. NDC 51803-002-02: 14 Unit dose, Foil Sealed, 65 mg Tablets (14 Tablets).

Also available: IOSAT™ (Potassium Iodide Tablets, USP 130 mg) Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 130 mg potassium iodide. NDC 51803-001-01: 14 Unit dose, Foil Sealed, 130 mg Tablets.

📦 Storage and Handling 12 words ▾

STORAGE AND HANDLING Store at 20-25°C (68-77°F). Keep dry and foil intact.

🧪 Active Ingredient 10 words ▾

Active Ingredients (in each tablet ) Potassium iodide 65 mg

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients magnesium stearate, microcrystalline cellulose, silica gel, sodium thiosulfate

🎯 Purpose 3 words ▾

Purpose Thyroid blocking

📋 Description 17 words ▾

DESCRIPTION Each white, round, cross-scored—the name IOSAT stamped on one side—tablet contains 65 mg of potassium iodide.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51803-0001-01 · Anbex 51810-0001-01 · Qilu →
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.