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ThyroSafe Potassium Iodide 65 mg Tablet, 3,200-count — NDC 50633-0910-20 package photo

ThyroSafe Potassium Iodide 65 mg Tablet, 3,200-count

by BTG International Inc. · 160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK
NDC 50633-0910-20
🏷️ FDA NDC (as labeled) 50633-910-20 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 50633-910-20
Product NDC 50633-910
11-digit billing NDC 50633091020
RxCUI 430174, 1086474
UNII 1C4QK22F9J
UPC 0350633910208
Application # ANDA076350
SPL Set ID 47762f8f-30e2-445d-aaa1-e04479f8dd5b
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-09-30
Route ORAL
Dosage form TABLET
Substance POTASSIUM IODIDE
Why two NDCs? The FDA registers this code as 50633-910-20 — 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 → 50633-0910-20. 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

LabelerBTG International Inc.
Application holderBTG INTERNATIONAL INC
FDA applicationANDA076350 (ANDA)
Labeler code50633
First marketedSep 2002
Product typeHuman Otc Drug
Portfolio6 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

📖 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
Size9 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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • 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 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.

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

The official label also statesInactive ingredients lactose, magnesium stearate, microcrystalline cellulose Questions or comments? call toll free +1 877 377 3784

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.
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 mgthis 50633-0910-20 BTG 3200 tablets — — FDA listed —
Iosat 65 mg 51803-0002-01 Anbex 20 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Sep 2002
📍
2026
Currently FDA-listed
24 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50633-0910-20 You're viewing this 160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK 2002-09-30 Active

🧭 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 50633-910-20, 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: 50633-0910-20, written without dashes as 50633091020. 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 50633-0910-20, the first segment (50633) is the labeler code FDA assigned to BTG International Inc.; the middle segment (0910) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 BTG International Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BTG International 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

DIRECTIONS FOR USE Use only as directed by public officials if a nuclear radiation emergency happens.

⏱️ Dosage and Administration ~3 min read ▾

Dose: Adults over 18 years 2 tablets (whole or crushed) every day (130 mg) Children over 12 years to 18 years who weigh at least 150 pounds 2 tablets (whole or crushed) every day (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) or 8 teaspoons every day (65 mg) Children over 3 years to 12 years 1 tablet (whole or crushed) or 8 teaspoons every day (65 mg) Children over 1 month to 3 years 4 teaspoons every day (32.5 mg) Babies at birth to 1 month 2 teaspoons every day (16.25 mg) Tablets can be crushed and mixed in many liquids.

To take the tablet in liquid solution, use dosing directions under Making a Potassium Iodide Liquid Mixture . Take KI every day (every 24 hours) as directed by public officials. Do not take more than 1 dose in 24 hours.

More will not help you. Too much medicine may increase the chances of side effects. Making a Potassium Iodide Liquid Mixture: Put one 65 mg KI tablet into a small bowl and grind it into a fine powder using the back of a metal teaspoon against the inside of the bowl.

The powder should not have any large pieces. Add 4 teaspoons of water to the crushed KI powder in the bowl and mix until the KI powder is dissolved in the water. Take the KI water mixture solution made in step 2 and mix it with 4 teaspoons of low fat white or chocolate milk, orange juice, flat soda, raspberry syrup, or infant formula.

The KI liquid mixture will keep for up to 7 days in the refrigerator. It is recommended that the KI liquid mixtures be prepared weekly. Throw away unused portions.

The amount of KI (65 mg tablet) in the drink when mixed as described above is 8.125 mg per teaspoon. The number of teaspoons of the drink to give your child depends on your child’s age as described in the following table: Child’s Age Give your child this amount in teaspoons Over 12 to 18 years old who weigh less than 150 pounds 8 teaspoons will give you a 65 mg dose Over 3 to 12 years old 8 teaspoons will give you a 65 mg dose Over 1 month to 3 years old 4 teaspoons will give you a 32.5 mg dose Birth to 1 month 2 teaspoons will give you a 16.25 mg dose Note: This is the amount to give your child for one single dose in teaspoons (not tablespoons).

You should give your child one dose each day as recommended by the public officials. Pregnant or breastfeeding women or babies under 1 month of age: Take as directed above and call a doctor as soon as possible. Repeat dosing should be avoided.

It is recommended that thyroid function be checked in babies less than 1 month of age that take KI. Women who are pregnant or breastfeeding should also be checked by a doctor if repeat dosing is necessary. Although these precautions should be taken, the benefits of short-term use of KI to block uptake of radioactive iodine by the thyroid gland far exceed its chances of side effects.

Patients with thyroid disease: If you have both a nodular thyroid condition such as multinodular goiter with heart disease, you should not take KI. Patients with other thyroid conditions may take KI as directed above, but call a doctor if you need to take KI for more than a few days.

⚠️ Warnings 77 words ▾

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.

🧪 Active Ingredient 14 words ▾

DESCRIPTION Each white, round, cross-scored ThyroSafe ® tablet contains 65 mg of potassium iodide.

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients lactose, magnesium stearate, microcrystalline cellulose Questions or comments? call toll free +1 877 377 3784

🎯 Purpose 21 words ▾

INDICATIONS ThyroSafe ® (Potassium Iodide Tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50633-0340-01 · BTG 50633-0920-20 · BTG →
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.