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Chlorthalidone 50 mg Tablet, 100-count — NDC 64980-0600-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorthalidone 50 mg Tablet, 100-count — NDC 64980-600-01 (Billing 64980-0600-01)

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Chlorthalidone 50 mg Tablet from Rising Pharma Holdings, Inc., marketed since Oct 2024 and currently FDA-listed; retail pharmacies pay about $0.1218 per tablet (NADAC). It is this product's only package size.

NDC 64980-0600-01
🏷️ FDA NDC (as labeled) 64980-600-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🚨
Active recall for this product.
Class II · Jun 5, 2026 — Failed Dissolution Specifications (Inventia Healthcare Limited) · FDA recall D-0610-2026
Lots / codes: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027 · reported Jun 24, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Chlorthalidone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64980-600-01
Product NDC 64980-600
11-digit billing NDC 64980060001
NCPDP billing unit EA — each (per item)
RxCUI 197499, 197500
UNII Q0MQD1073Q
UPC 0364980599108, 0364980599016, 0364980600019
Application # ANDA211320
SPL Set ID 71b1d074-0521-4cd1-beb5-fedd61f52eca
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 2024-10-23
Route ORAL
Dosage form TABLET
Substance CHLORTHALIDONE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 37600025000310
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
Quick answers
  • GSN (GCN sequence number): 008214
  • GCN: 34984
  • GPI-14 (Medi-Span): 37600025000310
  • HICL (First Databank): 003662
  • AHFS class code: 24:36.24.00
  • RxCUI (RxNorm): 197499
Why two NDCs? The FDA registers this code as 64980-600-01 — 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 → 64980-0600-01. 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.

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.

🧪 Full Chlorthalidone nutrient depletion report →
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.

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 $0.122 $12.18 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2219 $22.19 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2420 $24.20 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.145 $0.121
▼ Down 16% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64980-0600-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2024-10-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorthalidone 50 mg 00378-0213-01 Mylan 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 16714-0129-01 Northstar 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 27241-0217-01 Ajanta 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 29300-0334-01 Unichem 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 43598-0167-01 Dr. 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 43598-0720-01 Dr. 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 62135-0506-30 Chartwell 30 tablets $0.122 AB Availability likely —
Chlorthalidone Chlorthalidone 50 mg 62332-0677-31 Alembic 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 64980-0304-01 Rising 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mgthis 64980-0600-01 Rising 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 67877-0697-01 Ascend 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 68382-0971-01 Zydus 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 70756-0020-11 Lifestar 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 75834-0110-01 Nivagen 100 tablets $0.122 AB Availability likely —
Chlorthalidone 50 mg 51224-0118-50 TAGI 100 tablets $0.152 AB FDA listed +25%
Chlorthalidone 50 mg 59746-0761-01 JUBILANT 100 tablets $0.152 AB FDA listed +25%
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 mg 72789-0359-30 PD-Rx 30 tablets — AB FDA listed —
Chlorthalidone 50 mg 33342-0426-07 Macleods 30 tablets — AB FDA listed —
Chlorthalidone 50 mg 83980-0062-01 Ipca 100 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color Yellow / Green
ShapeRound
Imprint1;3
Size8 mm
ScoringScored — splits in 2
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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Application holderINVENTIA HEALTHCARE LTD
FDA applicationANDA211320 (ANDA)
Labeler code64980
First marketedOct 2024
Product typeHuman Prescription Drug
Portfolio525 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 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 pathological 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 120 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.

🆘 Overdosage 71 words ▾

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 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 207 words ▾

HOW SUPPLIED Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg tablets are light-yellow colored, round shaped, uncoated, flat, bevelled edge tablets, debossed with '103'on one side of the tablet and blank on the other side. They are available as follows: NDC 64980-599-01 Bottles of 100 with child-resistant closure NDC 64980-599-10 Bottles of 1000 with child-resistant closure The 50 mg tablets are light-green colored, round shaped, uncoated, flat, bevelled edge scored tablets, debossed with '1' to the left and '3'to the right of the score on one side of the tablet and blank on the other side.

They are available as follows: NDC 64980-600-01 Bottles of 100 with child-resistant closure Store at 20 to 25° C (68 to 77° F). [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed.

Avoid excessive heat. Dispense in a tight container as defined in the USP. Keep out of the reach of children.

This product should be dispensed in a container with a child-resistant cap. Manufactured by: Inventia Healthcare Limited, F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421 506 Maharashtra State, INDIA Code No.: MH/DRUGS/25/KD/638 Made in India Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 11/2024

📋 Description 98 words ▾

DESCRIPTION Chlorthalidone USP 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: Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in alcohol.

Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, ferric oxide yellow, magnesium stearate, microcrystalline cellulose. The 50 mg tablet also contains FD&C Blue #1. structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General: Hypokalemia may develop with chlorthalidone as with any other diuretic, especially with brisk diuresis when severe cirrhosis is present or during concomitant use of corticosteroids or ACTH. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate metabolic effects of hypokalemia especially with reference to myocardial activity.

Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather, appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone. Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy. Calcium excretion is decreased by thiazide-like drugs. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in few patients on thiazide therapy.

The common complications of hyperparathyroidism such as renal lithiasis, bone resorption and peptic ulceration have not been seen. 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. Laboratory Tests: Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. All patients receiving chlorthalidone should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia.

Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. 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: Chlorthalidone and related drugs may de… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 7 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label-01 label-02 label-03

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
39
Units reimbursed last 4 qtrs
1.7K
Gross reimbursed last 4 qtrs
$383.93
Avg / prescription
$9.84
Avg / unit
$0.2219
Latest quarter Q1 2026
28Rx
Medicaid pays / ea
$0.2219
gross reimbursed
vs
NADAC / ea
$0.1218
acquisition cost
=
Spread
+$0.1001
+82% 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 ⓘ
56% FFS 44% MCO
Fee-for-service · 22 Rx Managed care · 17 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 530 units · 5.3 per 100k residents MI New York: 1,200 units · 6.1 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: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.36.1
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 6.1 /100k
2 Michigan 5.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for 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.
← 64980-0599-01 · Rising 64980-0601-09 · Rising →
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.