HomeNDC LookupIngredientsChlorthalidone › 72789-0359-30
Chlorthalidone 50 mg Tablet, 30-count — NDC 72789-0359-30 package photo

Chlorthalidone 50 mg Tablet, 30-count

by PD-Rx Pharmaceuticals, Inc. · 30 TABLET in 1 BOTTLE, PLASTIC (72789-359-30)
NDC 72789-0359-30
🏷️ FDA NDC (as labeled) 72789-359-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2420/unit — full pricing hub ↓
Also comes in: 90 tablets 72789-0359-90
Rx only Generic 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) 72789-359-30
Product NDC 72789-359
11-digit billing NDC 72789035930
NCPDP billing unit EA — each (per item)
RxCUI 197499, 197500
UNII Q0MQD1073Q
UPC 0372789359304
Application # ANDA089286
SPL Set ID 08b7ee65-53a5-ffbb-e063-6294a90ad4ee
Established class (EPC) Thiazide-like Diuretic
Physiologic effect Increased Diuresis
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-27
Route ORAL
Dosage form TABLET
Substance CHLORTHALIDONE
GCN Seq No 008214
GCN 34984
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 CHLORTHALIDONE 50 MG TABLET
FDB brand name Chlorthalidone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72789-359-30 — 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 → 72789-0359-30. 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

LabelerPD-Rx Pharmaceuticals, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationANDA089286 (ANDA)
Labeler code72789
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio832 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 CHLORTHALIDONE 50 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 yellow / green
ShapeRound
ImprintMP;43
Size7 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 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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

9 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 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 · Q2 2026 $0.2420 $7.26 / 30 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
Chlorthalidone 50 mg 00378-0213-01 Mylan 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 16714-0129-01 Northstar 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 27241-0217-01 Ajanta 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 29300-0334-01 Unichem 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 43598-0167-01 Dr. 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 43598-0720-01 Dr. 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 62135-0506-30 Chartwell 30 tablets $0.121 AB Availability likely
Chlorthalidone Chlorthalidone 50 mg 62332-0677-31 Alembic 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 64980-0304-01 Rising 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 64980-0600-01 Rising 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 67877-0697-01 Ascend 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 68382-0971-01 Zydus 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 70756-0020-11 Lifestar 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 75834-0110-01 Nivagen 100 tablets $0.121 AB Availability likely
Chlorthalidone 50 mg 51224-0118-50 TAGI 100 tablets $0.152 AB FDA listed
Chlorthalidone 50 mg 59746-0761-01 JUBILANT 100 tablets $0.152 AB FDA listed
Chlorthalidone Chlorthalidone 50 mg 46708-0677-31 Alembic 100 tablets AB FDA listed
Chlorthalidone 50 mg 50090-5183-01 A-S 30 tablets AB FDA listed
Chlorthalidone 50 mg 51655-0477-52 Northwind 30 tablets AB FDA listed
Chlorthalidone 50 mg 51655-0961-52 Northwind 30 tablets AB FDA listed
Chlorthalidone 50 mg 57664-0649-18 Sun 1000 tablets AB FDA listed
Chlorthalidone 50 mg 60290-0005-01 Umedica 100 tablets AB FDA listed
Chlorthalidone 50 mg 63629-2465-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 50 mg 63629-4446-01 Bryant 90 tablets AB FDA listed
Chlorthalidone 50 mg 63629-8762-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 50 mg 63629-9298-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 50 mg 65162-0250-03 Amneal 30 tablets AB FDA listed
Chlorthalidone 50 mg 67046-1495-03 Coupler 30 tablets AB FDA listed
Chlorthalidone 50 mg 67046-1499-03 Coupler 30 tablets AB FDA listed
Chlorthalidone 50 mg 70771-1370-00 Zydus 1000 tablets AB FDA listed
Chlorthalidone 50 mg 71335-2580-01 Bryant 90 tablets AB FDA listed
Chlorthalidone 50 mg 71335-2956-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 50 mg 71335-3089-01 Bryant 90 tablets AB FDA listed
Chlorthalidone 50 mg 71610-0021-09 Aphena 9000 tablets AB FDA listed
Chlorthalidone 50 mg 72162-2010-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 50 mg 72162-2134-01 Bryant 100 tablets AB FDA listed
Chlorthalidone 50 mgthis 72789-0359-30 PD-Rx 30 tablets AB FDA listed
Chlorthalidone 50 mg 33342-0426-07 Macleods 30 tablets AB 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

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

Medicare Part D (outpatient prescription) spending for Chlorthalidone — the program that covers self-administered drugs. 16 manufacturers.
⚠️ 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 Chlorthalidone. 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
$11.31M
Claims incl. refills
733.1K
Beneficiaries
591.5K
Spend / beneficiary
$19.13
Spend / claim
$15.43
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.

🔬 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 Chlorthalidone — the ingredient across all brands.

Top reported reactions

Nausea1,258
Fatigue1,063
Diarrhoea849
Dizziness758
Headache715
Pain697
Dyspnoea665

Age at onset

Child1
Adolescent5
Adult1,324
Elderly1,411

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,310 594
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
72789-0359-30 You're viewing this 30 TABLET in 1 BOTTLE, PLASTIC (72789-359-30) 2023-10-27 Active
72789-0359-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-359-90) 2023-10-27 Active

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

Pack size FAQ

What quantity is in NDC 72789-0359-30?
NDC 72789-0359-30 is a 30-count package — 30 tablet in 1 bottle, plastic.
What is the difference between NDC 72789-0359-30 and NDC 72789-0359-90?
Both are Chlorthalidone 50 mg Tablet — the drug itself is identical. NDC 72789-0359-30 is the 30-count package, while NDC 72789-0359-90 is the 90 tablets package.
What NDC number is used to bill for this package of Chlorthalidone 50 mg Tablet?
Bill NDC 72789-0359-30 — the 11-digit billing format is 72789035930. 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

Finished prescription 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 ✓ Available
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 72789-359-30, 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: 72789-0359-30, written without dashes as 72789035930. 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 72789-0359-30, the first segment (72789) is the labeler code FDA assigned to PD-Rx Pharmaceuticals, Inc.; the middle segment (0359) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 PD-Rx Pharmaceuticals, 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 90 tablets (72789-0359-90). 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?
PD-Rx Pharmaceuticals, 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 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.

📄 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 ~1 min read

INDICATIONS AND USAGE Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.

Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women.

If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION Therapy should be initiated with the lowest possible dose. This dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. A single dose given in the morning with food is recommended; divided daily doses are unnecessary.

Hypertension Initiation: Therapy, in most patients, should be initiated with a single daily dose of 25 mg. If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. If additional control is required, the dosage of chlorthalidone may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added.

Dosage above 100 mg daily usually does not increase effectiveness. Increases in serum uric acid and decreases in serum potassium are dose-related over the 25 to 100 mg/day range. Maintenance: Maintenance doses may be lower than initial doses and should be adjusted according to individual patient response.

Effectiveness is well sustained during continued use. Edema Initiation: Adults, initially 50 to 100 mg daily, or 100 mg on alternate days. Some patients may require 150 to 200 mg at these intervals or up to 200 mg daily.

Dosages above this level, however, do not usually produce a greater response. Maintenance: Maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. Effectiveness is well sustained during continued use.

Contraindications 10 words

CONTRAINDICATIONS Anuria. Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.

⚠️ Warnings 111 words

WARNINGS Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone.

However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

🤒 Adverse Reactions 114 words

ADVERSE REACTIONS 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, vertigo, paresthesias, headache, xanthopsia.

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 Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics.

Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence. Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn.

🔄 Drug Interactions 126 words

Drug Interactions Chlorthalidone may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic peripheral adrenergic blocking drugs. Medication such as digitalis may also influence serum electrolytes.

Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting. Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Higher dosage of oral hypoglycemic agents may be required.

Latent diabetes mellitus may become manifest during chlorthalidone administration. Chlorthalidone and related drugs may increase the responsiveness to tubocurarine. Chlorthalidone and related drugs may decrease arterial responsiveness to norepinephrine.

This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

🔄 Drug / Laboratory Test Interactions 17 words

Drug/Laboratory Test Interactions Chlorthalidone and related drugs may decrease serum PBI levels without signs of thyroid disturbance.

🤰 Pregnancy 129 words

Pregnancy Teratogenic Effects. Pregnancy Category B Reproduction studies have been performed in the rat and the rabbit at doses up to 420 times the human dose and have revealed no evidence of harm to the fetus due to chlorthalidone. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects Thiazides cross the placental barrier and appear in cord blood. The use of chlorthalidone and related drugs in pregnant women requires that the anticipated benefits of the drug be weighed against possible hazards to the fetus.

These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

🧒 Pediatric Use 11 words

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

🆘 Overdosage 70 words

OVERDOSAGE Symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. The oral LD50 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 217 words

CLINICAL PHARMACOLOGY Chlorthalidone is an oral diuretic with prolonged action (48–72 hours) and low toxicity. The major portion of the drug is excreted unchanged by the kidneys. The diuretic effect of the drug occurs in approximately 2.6 hours and continues for up to 72 hours.

The mean half-life following a 50 to 200 mg dose is 40 hours. In the first order of absorption, the elimination half-life is 53 hours following a 50 mg dose, and 60 hours following a 100 mg dose. Approximately 75 percent of the drug is bound to plasma proteins, 58 percent of the drug being bound to albumin.

This is caused by an increased affinity of the drug to erythrocyte carbonic anhydrase. Nonrenal routes of elimination have yet to be clarified. Data are not available regarding percentage of dose as unchanged drug and metabolites, concentration of the drug in body fluids, degree of uptake by a particular organ or in the fetus, or passage across the blood-brain barrier.

The drug produces copious diuresis with greatly increased excretion of sodium and chloride. At maximal therapeutic dosage, chlorthalidone is approximately equal in its diuretic effect to comparable maximal therapeutic doses of benzothiadiazine diuretics. The site of action appears to be the cortical diluting segment of the ascending limb of Henle’s loop of the nephron.

📦 How Supplied / Storage and Handling 90 words

HOW SUPPLIED Chlorthalidone tablets, USP 25 mg are available as follows: Yellow, round, tablets, debossed MP 30 Bottles of 30 NDC 72789-358-30 Bottles of 90 NDC 72789-358-90 Chlorthalidone tablets, USP 50 mg are available as follows: Green, round, tablets, debossed MP 43 1. Bottles of 30 NDC 72789-359-30 2. Bottles of 90 NDC 72789-359-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

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

📋 Description 130 words

DESCRIPTION Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1-hydroxy- 3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula: Molecular Formula: C14H11ClN2O4S Molecular Weight: 338.76 Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol.

Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, povidone, lactose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. In addition, the 25 mg yellow tablets contain FD&C Yellow #6 Lake and D&C Yellow #10 Lake. The 50 mg green tablets contain FD&C Blue #1 Lake and D&C Yellow #10 Lake. structure

💬 Information for Patients 103 words

Information for Patients Patients should inform their physician if they have: (1) had an allergic reaction to chlorthalidone or other diuretics or have asthma, (2) kidney disease, (3) liver disease, (4) gout, (5) systemic lupus erythematosus, or (6) been taking other drugs such as cortisone, digitalis, lithium carbonate, or drugs for diabetes. 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 also be cautioned that taking alcohol can increase the chance of dizziness occurring.

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.