HomeNDC LookupIngredientsChlorthalidone › 70199-0017-30
Thalitone Chlorthalidone 15 mg Tablet, 30-count — NDC 70199-0017-30 package photo

Thalitone Chlorthalidone 15 mg Tablet, 30-count

by Casper Pharma LLC · 30 TABLET in 1 BOTTLE (70199-017-30)
NDC 70199-0017-30
🏷️ FDA NDC (as labeled) 70199-017-30 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$3.54 NADAC Per package$106.12 / 30 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.74/unit · Part D plans $3.61/unit — full pricing hub ↓
Also comes in: 100 tablets 70199-0017-01
Rx only 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 →
⚠️
Other active recalls for Chlorthalidone (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 5, 2026 — Failed Dissolution Specifications (Inventia Healthcare Limited) · FDA recall D-0610-2026
Class II · May 9, 2025 — Failed Dissolution Specifications (AvKARE) · FDA recall D-0461-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70199-017-30
Product NDC 70199-017
11-digit billing NDC 70199001730
NCPDP billing unit EA — each (per item)
UNII Q0MQD1073Q
Application # NDA019574
SPL Set ID bc5a0299-115b-4e60-bb3f-c75a95c51c15
Established class (EPC) Thiazide-like Diuretic
Physiologic effect Increased Diuresis
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-27
Route ORAL
Dosage form TABLET
Substance CHLORTHALIDONE
GPI-14 37600025000303
GCN Seq No 016837
GCN 34985
HICL code 003662
Ingredient (HICL) Chlorthalidone
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1F
Therapeutic class — specific (HIC3) Thiazide And Related Diuretics
AHFS code 24:36.24.00
AHFS class Thiazide-Like Diuretics (24:36)
FDB label name THALITONE 15 MG TABLET
FDB brand name Thalitone
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70199-017-30 — 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 → 70199-0017-30. 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 Thiazide-like Diuretic class.

Pharmacologic class Thiazide-like Diuretic
Drug family (ATC) Sulfonamides, plain
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

LabelerCasper Pharma LLC
Application holderCASPER PHARMA LLC
FDA applicationNDA019574 (NDA)
Labeler code70199
First marketedNov 2019
Product typeHuman Prescription Drug
Portfolio3 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 THALITONE 15 MG TABLET Ingredient Chlorthalidone
📖 What it is MedlinePlus · NLM

Chlorthalidone, a is used to treat high blood pressure and fluid retention. Chlorthalidone is in a class of medications called diuretics ('water pills'). It causes the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Chlorthalidone is a water pill — it helps your kidneys remove extra salt and fluid from your body. That lowers the pressure inside your blood vessels, which is why it's used for hi...
  • What exactly is chlorthalidone supposed to do for me?
  • Take it in the morning with food — that's the standard recommendation. Taking it in the morning means the increased urination it causes happens during the day while you're awake, r...
  • Should I take it in the morning or at night, and does it matter if I eat?
📖 Read our full Chlorthalidone guide →
8
Nutrient depletion considerations

Chlorthalidone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
ShapeFreeform
ImprintL;99
Size9 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 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

6 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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $3.537 $106.12 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $3.74 $112.28 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $3.61 $108.23 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jul 2023 Feb 2026 May 2026 Aug 2026 $3.549 $3.536
Flat over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thalitone 15 mgthis 70199-0017-30 Casper 30 tablets $3.537 Availability likely
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70199-0017-30, 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 – Q4 2025 · 4 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
765
Units reimbursed last 4 qtrs
32.1K
Gross reimbursed last 4 qtrs
$120K
Avg / prescription
$156.91
Avg / unit
$3.7428
Latest quarter Q4 2025
263Rx
Medicaid pays / ea
$3.7428
gross reimbursed
vs
NADAC / ea
$3.5374
acquisition cost
=
Spread
+$0.2054
+6% 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
62% FFS 38% MCO
Fee-for-service · 473 Rx Managed care · 292 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,948 units · 24.9 per 100k residents WA Idaho: 330 units · 16.8 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,588 units · 43.8 per 100k residents WI Michigan: no data reported MI New York: 10,885 units · 55.6 per 100k residents 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: 2,495 units · 21.2 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 2,024 units · 28.9 per 100k residents MA California: 3,933 units · 10.1 per 100k residents CA Utah: no data reported UT Colorado: 390 units · 6.6 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,380 units · 30.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 1,336 units · 36.9 per 100k residents 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: 3,555 units · 32.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 571 units · 12.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 186 units · 1.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 450 units · 1.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.555.6
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 New York 55.6 /100k
2 Wisconsin 43.8 /100k
3 Connecticut 36.9 /100k
4 North Carolina 32.8 /100k
5 Kentucky 30.5 /100k
6 Massachusetts 28.9 /100k
7 Washington 24.9 /100k
8 Ohio 21.2 /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.
100 tablets70199-0017-01 No Medicaid data
Drug total (last 4 qtrs): 765 Rx · 32,071 units · $120,034 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 · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Thalitone — 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 Thalitone. 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
$55.8K
Claims incl. refills
359
Beneficiaries
271
Spend / beneficiary
$205.98
Spend / claim
$155.49
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70199-0017-01 100 TABLET in 1 BOTTLE (70199-017-01) 2019-11-27 Active
70199-0017-30 You're viewing this 30 TABLET in 1 BOTTLE (70199-017-30) $3.54 / ea $106.12 2019-11-27 Active

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

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 70199-0017-30?
NDC 70199-0017-30 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 70199-0017-30 and NDC 70199-0017-01?
Both are Thalitone Chlorthalidone 15 mg Tablet — the drug itself is identical. NDC 70199-0017-30 is the 30-count package, while NDC 70199-0017-01 is the 100 tablets package.
What NDC number is used to bill for this package of Thalitone Chlorthalidone 15 mg Tablet?
Bill NDC 70199-0017-30 — the 11-digit billing format is 70199001730. 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.

📄 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 ~2 min read

1 INDICATIONS AND USAGE THALITONE is a thiazide-like diuretic indicated: • For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). • as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease, including nephrotic syndrome (1.2).

1.1Hypertension THALITONE ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.

There are no controlled trials demonstrating risk reduction with THALITONE. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.

The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

THALITONE can be used alone or in combination with other antihypertensive agents.

1.2Edema Chlorthalidone is indicated in adults as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease, including nephrotic syndrome.

⏱️ Dosage and Administration 192 words

2 DOSAGE AND ADMINISTRATION • Initiate therapy with the lowest possible dose, then titrate according to individual patient response (2.1). • Hypertension: Recommended initial dose is 15 mg daily with food. If additional blood pressure reduction is needed, increase the dose to 25 mg (2.2). • Edema: Recommended initial dose is 50 mg to 100 mg daily or 100 mg on alternate days. Depending on response, dosage can be decreased or increased up to a maximum of 200 mg daily (2.3).

2.1General Considerations THALITONE cannot be substituted with other formulations of chlorthalidone. Initiate therapy with the lowest possible dose, then titrate according to individual patient response.

2.2Hypertension The initial recommended dose is 15 mg once daily with food. After 2 weeks, the dosage may be increased to a single daily dose of 25 mg if additional blood pressure reduction is needed. Doses above 25 mg are not expected to result in increased blood pressure reduction.

2.3Edema The recommended initial dosage is 50 to 100 mg daily or 100 mg on alternate days. Depending on response, dosage can be decreased or increased up to a maximum of 200 mg daily.

💊 Dosage Forms and Strengths 54 words

3 DOSAGE FORMS AND STRENGTHS THALITONE 15 mg tablets are white biconvex, kidney shaped tablets with “L” on lower punch and “96” on the upper punch. THALITONE 25 mg tablets are white biconvex, kidney shaped tablets with “L” on one side and “99” on the other side. Tablets: 15 mg and 25 mg (3).

Contraindications 23 words

4 CONTRAINDICATIONS THALITONE is contraindicated in patients with anuria or hypersensitivity to chlorthalidone or other sulfonamide-derived drugs. • Anuria (4). • Hypersensitivity (4).

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS • Hypotension: Higher risk for patients with impaired sympathetic response, volume-depletion or salt restriction (5.1). • Renal Impairment: Patients with pre-existing kidney disease may be at higher risk. (5.2). • Monitor serum electrolytes periodically (5.3).

5.1Hypotension THALITONE may cause symptomatic hypotension. Patients with impaired sympathetic response, volume-depletion or who are salt restricted may be at increased risk for developing hypotension. If hypotension occurs, place the patient in the supine position and, if necessary, give intravenous normal saline.

A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

5.2Impaired Renal Function Changes in renal function including acute renal failure can be caused by diuretics. Patients with chronic kidney disease, heart failure, or volume depletion may be at particular risk of developing acute renal failure on THALITONE. Monitor renal function periodically. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on THALITONE [see Drug Interactions (7)].

5.3Electrolyte Abnormalities THALITONE can cause hypokalemia, hyponatremia, hypochloremic alkalosis, and hypomagnesemia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

If hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations), THALITONE should be discontinued. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides.

5.4Metabolic Disturbances Chlorthalidone may alter glucose tolerance. Chlorthalidone may raise serum levels of cholesterol and triglycerides. Chlorthalidone may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

Chlorthalidone decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving THALITONE.

🤒 Adverse Reactions 170 words

6 ADVERSE REACTIONS The following adverse reactions are described in more detail elsewhere in the label; • Hypotension [see Warnings and Precautions (5.1)] • Impaired Renal Function [see Warnings and Precautions (5.2)] • Electrolyte Abnormalities [see Warnings and Precautions (5.3)] • Metabolic Disturbances [see Warnings and Precautions (5.4)] The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central Nervous System Reactions : dizziness, paresthesias, headache. Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis).

Cardiovascular Reaction: Orthostatic hypotension. Other Adverse Reactions: muscle spasm, weakness, restlessness, impotence, xanthopsia. The most frequently expected adverse drug reactions among patients receiving THALITONE are hypotension, dizziness, renal dysfunction, and electrolyte abnormalities (6).

To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC at 1-844-5-CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 83 words

7 DRUG INTERACTIONS Effect of chlorthalidone on other drugs Chlorthalidone may add to or potentiate the action of other antihypertensive drugs. Chlorthalidone and related drugs may increase the responsiveness to tubocurarine. Lithium renal clearance is reduced by chlorthalidone, increasing the risk of lithium toxicity.

Monitor serum lithium levels during concomitant use. • Antihypertensive drugs: Chlorthalidone may add to or potentiate the action of other antihypertensive drugs (7). • Lithium: Lithium renal clearance is reduced by chlorthalidone, increasing the risk of lithium toxicity (7).

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm (8.1). • Lactation: Breastfeeding not recommended (8.2). • Pediatrics: Safety and efficacy in children have not been established (8.4). • Geriatric Use: No overall difference in responses versus younger patients but care should be taken in dose selection in patients with impaired renal function (8.5).

8.1Pregnancy Risk Summary Available data over decades from observational studies and reports with chlorthalidone use in pregnant women have not identified a drug-associated risk of major birth defects or miscarriage. However, adverse fetal outcomes, including fetal or neonatal jaundice, thrombocytopenia, hypoglycemia, and electrolyte abnormalities have been reported following maternal use of thiazide diuretics ( see Clinical Considerations ). Chlorthalidone should not be used as first-line therapy to treat hypertension in pregnancy.

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and stillbirth.

Fetal/Neonatal Adverse Reactions Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Thiazides, like other diuretics, can cause placental hypoperfusion. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, hypoglycemia, and electrolyte abnormalities.

Thiazides do not prevent or alter the course of EPH (Edema, Proteinuria, Hypertension) gestosis (pre-eclampsia) and should not be used as first-line therapy to treat hypertension in pregnant women. Data Animal Data Reproduction studies have been performed in the rat and the rabbit and have revealed no evidence of harm to the fetus due to chlorthalidone.The available data do not allow the calculation of comparisons between the exposure of chlorthalidone observed in animal studies to the systemic exposure that would be expected in humans.

8.2Lactation Risk Summary Chlorthalidone is present in human milk. There is no information regarding the effects of chlorthalidone on the breastfed infant or the effects on milk production. Because of the potential for chlorthalidone accumulation which may lead to serious adverse reactions in the breastfed infant (such as jaundice, thrombocytopenia, hyperglycemia, electrolyte abnormalities), advise patients that breastfeeding is not recommended during treatment with chlorthalidone.

8.4Pediatric Use Safety and effectiveness in children have not been established.

8.5Geriatric Use Clinical studies of THALITONE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function,…

🤰 Pregnancy ~1 min read

8.1Pregnancy Risk Summary Available data over decades from observational studies and reports with chlorthalidone use in pregnant women have not identified a drug-associated risk of major birth defects or miscarriage. However, adverse fetal outcomes, including fetal or neonatal jaundice, thrombocytopenia, hypoglycemia, and electrolyte abnormalities have been reported following maternal use of thiazide diuretics ( see Clinical Considerations ). Chlorthalidone should not be used as first-line therapy to treat hypertension in pregnancy.

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and stillbirth.

Fetal/Neonatal Adverse Reactions Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Thiazides, like other diuretics, can cause placental hypoperfusion. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, hypoglycemia, and electrolyte abnormalities.

Thiazides do not prevent or alter the course of EPH (Edema, Proteinuria, Hypertension) gestosis (pre-eclampsia) and should not be used as first-line therapy to treat hypertension in pregnant women. Data Animal Data Reproduction studies have been performed in the rat and the rabbit and have revealed no evidence of harm to the fetus due to chlorthalidone.The available data do not allow the calculation of comparisons between the exposure of chlorthalidone observed in animal studies to the systemic exposure that would be expected in humans.

🧒 Pediatric Use 12 words

8.4Pediatric Use Safety and effectiveness in children have not been established.

🧓 Geriatric Use 139 words

8.5Geriatric Use Clinical studies of THALITONE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 72 words

10 OVERDOSAGE Symptoms of acute overdosage include nausea, weakness, dizziness and disturbances of electrolyte balance. The oral LD 50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established.

There is no specific antidote but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Chlorthalidone is a long-acting oral diuretic with antihypertensive activity. The diuretic effects of chlorthalidone and the benzothiadiazine (thiazide) diuretics appear to arise from similar mechanisms and the maximal effect of chlorthalidone and the thiazides appear to be similar. The site of the action appears to be the distal convoluted tubule of the nephron.

Although the mechanism of action of chlorthalidone and related drugs is not wholly clear, sodium and water depletion appear to provide a basis for its antihypertensive effect.

12.2Pharmacodynamics The diuretic action of chlorthalidone commences a mean of 2.6 hours after dosing and continues for up to 72 hours. The drug produces diuresis with increased excretion of sodium and chloride. The diuretic effects of chlorthalidone lead to decreased extracellular fluid volume, plasma volume, cardiac output, total exchangeable sodium, glomerular filtration rate, and renal plasma flow.

Chlorthalidone produces dose-related reductions in serum potassium levels, elevations in serum uric acid and blood glucose, and it can lead to decreased sodium and chloride levels.

12.3Pharmacokinetics Absorption THALITONE (chlorthalidone USP) has been formulated with PVP (povidone polyvinylpyrrolidone), a bioavailability enhancer that provides 104% to 116% bioavailability relative to an oral solution of chlorthalidone [see Clinical Studies (14)]. THALITONE cannot be substituted with other formulations of chlorthalidone. Distribution In the blood, approximately 75% of the drug is bound to plasma proteins over a concentration range of 0.2 to 7.7 ug/mL.

Elimination The mean plasma half-life of chlorthalidone is about 40 to 60 hours. It is eliminated primarily as unchanged drug in the urine.

🧬 Mechanism of Action 84 words

12.1Mechanism of Action Chlorthalidone is a long-acting oral diuretic with antihypertensive activity. The diuretic effects of chlorthalidone and the benzothiadiazine (thiazide) diuretics appear to arise from similar mechanisms and the maximal effect of chlorthalidone and the thiazides appear to be similar. The site of the action appears to be the distal convoluted tubule of the nephron.

Although the mechanism of action of chlorthalidone and related drugs is not wholly clear, sodium and water depletion appear to provide a basis for its antihypertensive effect.

📦 How Supplied / Storage and Handling 105 words

16 HOW SUPPLIED/STORAGE AND HANDLING THALITONE (chlorthalidone) Tablets USP 15 mg are white biconvex, kidney shaped tablets with “L” on lower punch and “96” on the upper punch. Bottles of 30 NDC 70199-017-30 Bottles of 100 NDC 70199-017-01 THALITONE (chlorthalidone) Tablets USP 25 mg are white biconvex, kidney shaped tablets with “L” on one side and “99” on the other side. Bottles of 30 NDC 70199-001-30 Bottles of 100 NDC 70199-001-01 Store at 20 o to 25 o C (68 o to 77 o F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 90 words

11 DESCRIPTION THALITONE (chlorthalidone USP) is an antihypertensive/diuretic supplied as 15 mg and 25 mg tablets for oral use. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double ring system is incorporated in its structure. It is a racemic mixture of 2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide, with the following structural formula: Chlorthalidone is practically insoluble in water, in ether and in chloroform; soluble in methanol; slightly soluble in alcohol.

The inactive ingredients are colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. chlorthalidone-struc-1.jpg

💬 Information for Patients 150 words

17 PATIENT COUNSELING INFORMATION • Patients should inform their doctor if they have had an allergic reaction to chlorthalidone or other diuretics; kidney disease; gout; been taking lithium carbonate. • Patients should be cautioned to contact their physician if they experience any of the following symptoms of potassium loss: excess thirst, tiredness, drowsiness, restlessness, muscle pains or cramps, nausea, vomiting or increased heart rate or pulse. • Patients should inform their doctor if they have symptoms of light-headedness or dizziness. • Pregnancy Advise a pregnant woman of the potential risk to a fetus.

Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)] . • Lactation Advise females not to breastfeed during treatment with chlorthalidone [see Use in Specific Populations (8.2)] . Rx Only PIB00101-05 Manufactured for: Casper Pharma LLC East Brunswick, NJ 08816 Made in India. Revised: 12/2019

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.