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Chlorthalidone 25 mg Tablet, 1,000-count — NDC 62332-0676-91 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorthalidone 25 mg Tablet, 1,000-count — NDC 62332-676-91 (Billing 62332-0676-91)

by Alembic Pharmaceuticals Inc. · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Chlorthalidone 25 mg Tablet from Alembic Pharmaceuticals Inc., marketed since Aug 2022 and currently FDA-listed.

NDC 62332-0676-91
🏷️ FDA NDC (as labeled) 62332-676-91 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2420/unit — full pricing hub ↓
Product page 62332-0676-31 Also comes in: 90 tablets 62332-676-90 100 tablets 62332-676-31
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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62332-676-91
Product NDC 62332-676
11-digit billing NDC 62332067691
RxCUI 197499, 197500
UNII Q0MQD1073Q
UPC 0362332677900
Application # ANDA216262
SPL Set ID a1043a72-8e64-49da-a7e4-eadee083022e
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 2022-08-29
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 37600025000305
GCN Seq No 008213
GCN 34982
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 25 MG TABLET
FDB brand name Chlorthalidone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008213
  • GCN: 34982
  • GPI-14 (Medi-Span): 37600025000305
  • HICL (First Databank): 003662
  • AHFS class code: 24:36.24.00
  • RxCUI (RxNorm): 197499
Why two NDCs? The FDA registers this code as 62332-676-91 — 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 → 62332-0676-91. 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 25 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 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 $242.00 / 1000 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
62332-0676-31 62332-676-31 Main listing 100 TABLET in 1 BOTTLE $0.0743 / ea $7.43 2022-08-29 — Active
62332-0676-90 62332-676-90 90 TABLET in 1 BOTTLE — — 2022-08-29 — Active
62332-0676-91 You're viewing this 1000 TABLET in 1 BOTTLE — — 2022-08-29 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 62332-0676-90?
Both are Chlorthalidone 25 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 62332-0676-90 is the 90 tablets package.
What NDC number is used to bill for this package of Chlorthalidone 25 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorthalidone 25 mg 00378-0222-01 Mylan 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 00904-6900-04 Major 30 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 16714-0128-01 Northstar 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 27241-0216-01 Ajanta 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 29300-0333-01 Unichem 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 43598-0170-01 Dr. 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 43598-0719-01 Dr. 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 50268-0167-15 AvPAK 50 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 51079-0058-20 Mylan 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 60687-0317-01 American 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 62135-0505-30 Chartwell 30 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 64980-0303-01 Rising 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 64980-0599-01 Rising 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 67877-0696-01 Ascend 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 68382-0970-01 Zydus 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 70756-0011-11 Lifestar 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 75834-0109-01 Nivagen 100 tablets $0.074 AB Availability likely —
Chlorthalidone 25 mg 51224-0018-50 TAGI 100 tablets $0.087 AB FDA listed —
Chlorthalidone 25 mg 59746-0760-01 JUBILANT 100 tablets $0.087 AB FDA listed —
Chlorthalidone 25 mg 00904-7583-04 Major 30 tablets — AB FDA listed —
Chlorthalidone Chlorthalidone 25 mg 46708-0676-31 Alembic 100 tablets — AB FDA listed —
Chlorthalidone 25 mg 48433-0021-20 Safecor 100 tablets — AB FDA listed —
Chlorthalidone 25 mg 50090-5643-01 A-S 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 50090-6126-01 A-S 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 50090-6957-01 A-S 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 50090-6958-00 A-S 90 tablets — AB FDA listed —
Chlorthalidone 25 mg 50090-7831-00 A-S 90 tablets — AB FDA listed —
Chlorthalidone 25 mg 51655-0526-26 Northwind 90 tablets — AB FDA listed —
Chlorthalidone 25 mg 51655-0790-26 Northwind 90 tablets — AB FDA listed —
Chlorthalidone 25 mg 51655-0992-52 Northwind 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 55289-0067-30 PD-Rx 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 57664-0648-18 Sun 1000 tablets — AB FDA listed —
Chlorthalidone 25 mg 60290-0004-01 Umedica 100 tablets — AB FDA listed —
Chlorthalidone Chlorthalidone 25 mgthis 62332-0676-91 Alembic 1000 tablets — AB FDA listed —
Chlorthalidone 25 mg 63629-8761-01 Bryant 100 tablets — AB FDA listed —
Chlorthalidone 25 mg 65162-0247-03 Amneal 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 68788-4053-03 Preferred 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 68788-4077-03 Preferred 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 68788-8294-09 Preferred 90 tablets — AB FDA listed —
Chlorthalidone 25 mg 70518-3718-00 REMEDYREPACK 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 70518-3954-00 REMEDYREPACK 30 tablets — AB Discontinued —
Chlorthalidone 25 mg 70518-4578-00 REMEDYREPACK 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 70771-1369-00 Zydus 1000 tablets — AB FDA listed —
Chlorthalidone 25 mg 71205-0592-30 Proficient 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-0906-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-1829-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-2072-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-2223-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-2269-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-2935-01 Bryant 1000 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-3074-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71335-3124-01 Bryant 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71610-0029-09 Aphena 9000 tablets — AB FDA listed —
Chlorthalidone 25 mg 71610-0472-30 Aphena 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 71610-0682-16 Aphena 6000 tablets — AB FDA listed —
Chlorthalidone 25 mg 72162-2133-00 Bryant 1000 tablets — AB FDA listed —
Chlorthalidone 25 mg 72189-0356-60 Direct_Rx 60 tablets — AB FDA listed —
Chlorthalidone 25 mg 72189-0507-60 Direct_Rx 60 tablets — AB FDA listed —
Chlorthalidone 25 mg 72189-0644-60 Direct_Rx 60 tablets — AB FDA listed —
Chlorthalidone 25 mg 72789-0358-30 PD-Rx 30 tablets — AB FDA listed —
Thalitone 25 mg 70199-0001-01 Casper 100 tablets — — Discontinued —
Chlorthalidone 25 mg 68788-4169-03 Preferred 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 33342-0425-07 Macleods 30 tablets — AB FDA listed —
Chlorthalidone 25 mg 83980-0061-01 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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 Green
ShapeRound
ImprintL;77
Size7 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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • 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 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 AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • 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.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA216262 (ANDA)
Labeler code62332
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio492 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 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 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 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 131 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. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 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 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 219 words ▾

CLINICAL PHARMACOLOGY Chlorthalidone is an oral diuretic with prolonged action (48 to 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 171 words ▾

HOW SUPPLIED Chlorthalidone tablets, USP are available containing 25 mg or 50 mg of chlorthalidone, USP. The 25 mg tablets are light green, round, flat face, beveled-edge tablets, debossed ‘1L’ on one side and plain the other side. They are available as follows: Bottle of 90 tablets with child resistant closure, NDC 62332-676-90 Bottle of 100 tablets with child resistant closure, NDC 62332-676-31 Bottle of 1000 tablets, NDC 62332-676-91 The 50 mg tablets having functional scoring are light green, round, flat face, beveled-edge tablets, bisected on one side with debossed ‘L’ above the bisect and debossed ‘77’ below the bisect, plain the other side.

They are available as follows: Bottle of 90 tablets with child resistant closure, NDC 62332-677-90 Bottle of 100 tablets with child resistant closure, NDC 62332-677-31 Bottle of 1000 tablets, NDC 62332-677-91 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 116 words ▾

DESCRIPTION Chlorthalidone 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: C 14 H 11 ClN 2 O 4 S Molecular weight: 338.76 Chlorthalidone, USP is practically insoluble in water and dichloromethane; soluble in acetone and methanol; slightly soluble in 96% ethanol.

Chlorthalidone tablets, USP are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate, colloidal silicon dioxide, stearic acid and colorants D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum 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.

⚠️ 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 d… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 46 words ▾

Nursing Mothers Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from chlorthalidone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 9 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No information is available.

📄 Package Label / Principal Display Panel 40 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg NDC 62332-676-90 Chlorthalidone Tablets, USP 25 mg Rx only 90 Tablets Alembic 90 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 50 mg NDC 62332-677-90 Chlorthalidone Tablets, USP 50 mg Rx only 90 Tablets Alembic 90 tablets

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

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

Medicare Part D (outpatient prescription) spending for Chlorthalidone (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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 CHLORTHALIDONE (this brand).

Top reported reactions

Fatigue905
Nausea741
Diarrhoea685
Dizziness579
Pain560
Headache541
Dyspnoea526

Age at onset

Child1
Adolescent4
Adult1,116
Elderly1,254

Reporter sex

11,482 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization3,682
Life-threatening350
Disabling211
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1,127 0
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Alembic 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 2 other package presentations of this same product, including 90 tablets (62332-0676-90), 100 tablets (62332-0676-31). 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?
Alembic 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.
← 62332-0663-30 · Alembic 62332-0677-31 · Alembic →
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.