HomeNDC LookupIngredientsChlorthalidone › 75834-0109-01
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(from DailyMed)

Chlorthalidone 25 mg Tablet, 100-count

by Nivagen Pharmaceuticals, INC. · 100 TABLET in 1 BOTTLE (75834-109-01)
NDC 75834-0109-01
🏷️ FDA NDC (as labeled) 75834-109-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0840 NADAC Per package$8.40 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2144/unit · Part D plans $0.2420/unit — full pricing hub ↓
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) 75834-109-01
Product NDC 75834-109
11-digit billing NDC 75834010901
NCPDP billing unit EA — each (per item)
RxCUI 197499, 197500
UNII Q0MQD1073Q
UPC 0375834109015, 0375834110011
Application # ANDA207222
SPL Set ID 36ef8d83-45f2-4873-b7cb-1be096d14d18
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 2018-05-28
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 75834-109-01 — 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 → 75834-0109-01. 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

LabelerNivagen Pharmaceuticals, INC.
Application holderUMEDICA LABORATORIES PRIVATE LTD
FDA applicationANDA207222 (ANDA)
Labeler code75834
First marketedMay 2018
Product typeHuman Prescription Drug
Portfolio95 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.

🧪 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 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.084 $8.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2144 $21.44 / 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 mg 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 mgthis 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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 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 75834-0109-01, 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
5.8K
Units reimbursed last 4 qtrs
228.3K
Gross reimbursed last 4 qtrs
$48.9K
Avg / prescription
$8.43
Avg / unit
$0.2144
Latest quarter Q4 2025
1.4KRx
Medicaid pays / ea
$0.2144
gross reimbursed
vs
NADAC / ea
$0.0840
acquisition cost
=
Spread
+$0.1304
+155% 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
42% FFS 58% MCO
Fee-for-service · 2,451 Rx Managed care · 3,355 Rx
State Medicaid map
Alaska: 465 units · 63.4 per 100k residents AK Maine: no data reported ME Washington: 7,808 units · 99.9 per 100k residents WA Idaho: no data reported ID Montana: 495 units · 43.7 per 100k residents MT North Dakota: no data reported ND Minnesota: 2,132 units · 37.2 per 100k residents MN Wisconsin: 14,367 units · 243 per 100k residents WI Michigan: 56,426 units · 562 per 100k residents MI New York: 60,911 units · 311 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 288 units · 6.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,125 units · 66.3 per 100k residents IA Illinois: 3,705 units · 29.5 per 100k residents IL Indiana: 2,460 units · 35.8 per 100k residents IN Ohio: 4,553 units · 38.6 per 100k residents OH Pennsylvania: 6,222 units · 48.0 per 100k residents PA New Jersey: 4,538 units · 48.8 per 100k residents NJ Massachusetts: 1,977 units · 28.2 per 100k residents MA California: 20,770 units · 53.3 per 100k residents CA Utah: no data reported UT Colorado: 808 units · 13.7 per 100k residents CO Nebraska: 1,325 units · 67.0 per 100k residents NE Missouri: 3,608 units · 58.2 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 660 units · 7.6 per 100k residents VA Maryland: 540 units · 8.7 per 100k residents MD Connecticut: 3,557 units · 98.3 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 2,745 units · 130 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 7,630 units · 70.4 per 100k residents NC South Carolina: 390 units · 7.3 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,129 units · 68.4 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 875 units · 7.9 per 100k residents GA D.C.: 5,852 units · 862 per 100k residents DC Hawaii: 375 units · 26.1 per 100k residents HI Texas: 1,050 units · 3.4 per 100k residents TX Florida: 2,985 units · 13.2 per 100k residents FL
Units reimbursed · per 100k residents
3.4862
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. 862 /100k
2 Michigan 562 /100k
3 New York 311 /100k
4 Wisconsin 243 /100k
5 New Mexico 130 /100k
6 Washington 99.9 /100k
7 Connecticut 98.3 /100k
8 North Carolina 70.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets75834-0109-10 9,815 Rx · $104,655
Drug total (last 4 qtrs): 15,621 Rx · 702,449 units · $153,586 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for 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 Per unit Per pack Marketing startStatus
75834-0109-01 You're viewing this 100 TABLET in 1 BOTTLE (75834-109-01) $0.0840 / ea $8.40 2018-05-28 Active
75834-0109-10 1000 TABLET in 1 BOTTLE (75834-109-10) $0.0840 / ea $83.97 2018-05-28 Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0840 NADAC).

This pack accounts for about 37% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 75834-0109-01?
NDC 75834-0109-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 75834-0109-01 and NDC 75834-0109-10?
Both are Chlorthalidone 25 mg Tablet — the drug itself is identical. NDC 75834-0109-01 is the 100-count package, while NDC 75834-0109-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Chlorthalidone 25 mg Tablet?
Bill NDC 75834-0109-01 — the 11-digit billing format is 75834010901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE Diuretics such as chlorthalidone are indicated in the management of hypertension either alone or in combination with other antihypertensive drugs. 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 cardio vascular 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, then titrated according to individual patient response. 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 15 mg.

If the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 25 mg. If additional control is required, the dosage of chlorthalidone may be increased to 30-50 mg once daily or 100 mg once daily. A second antihypertensive drug (step 2 therapy) may be added, as necessary.

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 15 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 30 to 100 mg daily, or 100 mg on alternate days. Some patients may require 90 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 and Cautions ~2 min read

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. 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.

🤒 Adverse Reactions 115 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). Cardio vascular 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. Geriatric Use Clinical studies of the 15 mg chlorthalidone tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with 15 mg chlorthalidone tablets has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 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 ~1 min read

HOW SUPPLIED Chlorthalidone Tablets, USP are available containing 25 mg or 50 mg of Chlorthalidone, USP. 25 mg Tablets are Light yellow colour, round, unscored tablet, debossed with "N" on one side and plain on other side. 25 mg Tablets are supplied as follows: Bottles of 100 tablets NDC # 75834-109-01 Bottles of 1000 tablets NDC # 75834-109-10 50 mg Tablets are Light green colour, round tablet, debossed with "N" and score line on one side and plain on other side.

50 mg Tablets are supplied as follows: Bottles of 100 tablets NDC # 75834-110-01 Bottles of 1000 tablets NDC # 75834-110-10 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. ANIMAL PHARMACOLOGY Biochemical studies in animals have suggested reasons for the prolonged effect of chlorthalidone.

Absorption from the gastrointestinal tract is slow due to its low solubility. After passage to the liver, some of the drug enters the general circulation, while some is excreted in the bile, to be reabsorbed later. In the general circulation, it is distributed widely to the tissues, but is taken up in highest concentrations by the kidneys, where amounts have been found 72 hours after ingestion, long after it has disappeared from other tissues.

The drug is excreted unchanged in the urine. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Manufactured by: Umedica Laboratories Pvt.

Ltd. Plot No.221 and 221/1, GIDC, II nd Phase, Vapi, Gujarat 396195, India (IND) Manufactured by: Square Pharmaceuticals Limited Dhaka Unit, Kaliakoir, Gazipur – 1750, Bangladesh. Revised July 2023, V-03

📋 Description 147 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: chlorthalidone-strecture Molecular Formula: C 14 H 11 ClN 2 O 4 S Molecular weight: 338.776 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: microcrystalline cellulose, partially pregelatinized maize starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, ingredients of aquadry blend yellow like iron oxide yellow, lactose monohydrate, Ferrosoferric Oxide for 25 mg and ingredients of aquadry blend green like D & C Yellow #10 aluminum lake, FD & C blue #1/ Brilliant Blue FCF Aluminum Lake for 50 mg.

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.