HomeNDC LookupIngredientsChlorthalidone › 16714-0128-01
Chlorthalidone 25 mg Tablet, 100-count — NDC 16714-0128-01 package photo

Chlorthalidone 25 mg Tablet, 100-count

by Northstar Rx LLC. · 100 TABLET in 1 BOTTLE (16714-128-01)
NDC 16714-0128-01
🏷️ FDA NDC (as labeled) 16714-128-01 billing pads the product segment with a zero
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) 16714-128-01
Product NDC 16714-128
11-digit billing NDC 16714012801
NCPDP billing unit EA — each (per item)
RxCUI 197499, 197500
UNII Q0MQD1073Q
Application # ANDA207813
SPL Set ID 56635d7a-1fff-4d1f-bf2c-def4b1ad8208
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 2019-11-21
Route ORAL
Dosage form TABLET
Substance CHLORTHALIDONE
GPI-14 37600025000305
GPI class Chlorthalidone
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 16714-128-01 — 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 → 16714-0128-01. 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.

🏭 Manufacturer & labeler

LabelerNorthstar Rx LLC.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA207813 (ANDA)
Labeler code16714
First marketedNov 2019
Product typeHuman Prescription Drug
Portfolio28 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 25 MG TABLET Ingredient Chlorthalidone
📗 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 / White
ShapeRound
ImprintZ;50
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.084 $8.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2661 $26.61 / 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 2021 Jul 2022 Dec 2025 Aug 2026 $0.171 $0.083
▼ Down 51% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorthalidone 25 mg 00378-0222-01 Mylan 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 00904-6900-04 Major 30 tablets $0.084 AB Availability likely
Chlorthalidone 25 mgthis 16714-0128-01 Northstar 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 27241-0216-01 Ajanta 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 29300-0333-01 Unichem 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 43598-0170-01 Dr. 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 43598-0719-01 Dr. 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 50268-0167-15 AvPAK 50 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 51079-0058-20 Mylan 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 60687-0317-01 American 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 62135-0505-30 Chartwell 30 tablets $0.084 AB Availability likely
Chlorthalidone Chlorthalidone 25 mg 62332-0676-31 Alembic 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 64980-0303-01 Rising 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 64980-0599-01 Rising 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 67877-0696-01 Ascend 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 68382-0970-01 Zydus 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 70756-0011-11 Lifestar 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 75834-0109-01 Nivagen 100 tablets $0.084 AB Availability likely
Chlorthalidone 25 mg 51224-0018-50 TAGI 100 tablets $0.087 AB FDA listed +3%
Chlorthalidone 25 mg 59746-0760-01 JUBILANT 100 tablets $0.087 AB FDA listed +3%
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 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
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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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.

🗺️ 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 16714-0128-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
22.1K
Units reimbursed last 4 qtrs
922.4K
Gross reimbursed last 4 qtrs
$245.5K
Avg / prescription
$11.09
Avg / unit
$0.2661
Latest quarter Q4 2025
4.4KRx
Medicaid pays / ea
$0.2661
gross reimbursed
vs
NADAC / ea
$0.0840
acquisition cost
=
Spread
+$0.1821
+217% 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
32% FFS 68% MCO
Fee-for-service · 7,077 Rx Managed care · 15,061 Rx
State Medicaid map
Alaska: 13,799 units · 1,883 per 100k residents AK Maine: 4,335 units · 311 per 100k residents ME Washington: 36,167 units · 463 per 100k residents WA Idaho: 9,487 units · 483 per 100k residents ID Montana: 13,589 units · 1,200 per 100k residents MT North Dakota: 2,576 units · 329 per 100k residents ND Minnesota: 21,448 units · 374 per 100k residents MN Wisconsin: 23,899 units · 404 per 100k residents WI Michigan: 29,308 units · 292 per 100k residents MI New York: 39,367 units · 201 per 100k residents NY Vermont: 1,380 units · 213 per 100k residents VT New Hampshire: 1,150 units · 82.0 per 100k residents NH Oregon: 53,858 units · 1,272 per 100k residents OR Nevada: 7,078 units · 222 per 100k residents NV Wyoming: 375 units · 64.2 per 100k residents WY South Dakota: 2,106 units · 229 per 100k residents SD Iowa: 6,844 units · 213 per 100k residents IA Illinois: 87,914 units · 701 per 100k residents IL Indiana: 18,968 units · 276 per 100k residents IN Ohio: 32,073 units · 272 per 100k residents OH Pennsylvania: 33,450 units · 258 per 100k residents PA New Jersey: 13,617 units · 147 per 100k residents NJ Massachusetts: 11,373 units · 162 per 100k residents MA California: no data reported CA Utah: 5,220 units · 153 per 100k residents UT Colorado: 34,266 units · 583 per 100k residents CO Nebraska: 6,149 units · 311 per 100k residents NE Missouri: 30,529 units · 493 per 100k residents MO Kentucky: 44,268 units · 978 per 100k residents KY West Virginia: 13,790 units · 779 per 100k residents WV Virginia: 29,424 units · 338 per 100k residents VA Maryland: 20,943 units · 339 per 100k residents MD Connecticut: 12,632 units · 349 per 100k residents CT Rhode Island: 3,747 units · 342 per 100k residents RI Arizona: 24,128 units · 325 per 100k residents AZ New Mexico: 13,143 units · 622 per 100k residents NM Kansas: 1,091 units · 37.1 per 100k residents KS Arkansas: 14,892 units · 486 per 100k residents AR Tennessee: 14,359 units · 202 per 100k residents TN North Carolina: 21,979 units · 203 per 100k residents NC South Carolina: 11,933 units · 222 per 100k residents SC Delaware: 1,778 units · 172 per 100k residents DE Oklahoma: 11,287 units · 278 per 100k residents OK Louisiana: 38,690 units · 846 per 100k residents LA Mississippi: 10,875 units · 370 per 100k residents MS Alabama: 29,788 units · 583 per 100k residents AL Georgia: 14,874 units · 135 per 100k residents GA D.C.: 17,696 units · 2,606 per 100k residents DC Hawaii: 2,925 units · 204 per 100k residents HI Texas: 14,443 units · 47.3 per 100k residents TX Florida: 13,414 units · 59.3 per 100k residents FL
Units reimbursed · per 100k residents
37.12,606
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 D.C. 2,606 /100k
2 Alaska 1,883 /100k
3 Oregon 1,272 /100k
4 Montana 1,200 /100k
5 Kentucky 978 /100k
6 Louisiana 846 /100k
7 West Virginia 779 /100k
8 Illinois 701 /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.

🔬 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
16714-0128-01 You're viewing this 100 TABLET in 1 BOTTLE (16714-128-01) 2019-11-21 Active

📄 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 tablets, USP 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 tablets, USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone tablets, USP 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 ~2 min read

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 decrease serum PBI levels without signs of thyroid disturbance. Carcinogenesis , Mutagenesis , Impairment of Fertility No information is available.

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. 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.

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

🤰 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.

🆘 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 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 145 words

HOW SUPPLIED Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. The 25 mg tablets are light yellow, round, flat faced beveled edged unscored tablets debossed with "Z25" on one side of the tablet and plain on other side. They are available as follows: NDC 16714-128-01 in bottle of 100 tablets with child-resistant closure The 50 mg tablets are white to off white, round, flat faced beveled edged, scored tablets debossed with 'Z' and '50' on either side of score line on one side of the tablet and plain on the other side.

They are available as follows: NDC 16714-129-01 in bottle of 100 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 133 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 : C 14 H 11 ClN 2 O 4 S Molecular weight: 338.76 Chlorthalidone, USP is white to yellowish-white, crystalline powder that melts at a temperature 216°C to 222°C, with decomposition.

It is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in alcohol. Chlorthalidone tablets, USP are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, corn starch,microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid.Additionally 25 mg tablet contain ferric oxide yellow. Chlorthalidone tablets, USP

💬 Information for Patients 154 words

INFORMATION FOR PATIENTS Patients should inform their physician if they have: had an allergic reaction to chlorthalidone or other diuretics or have asthma kidney disease liver disease gout systemic lupus erythematosus 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 T ests 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.

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.