Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet, 30-count — NDC 72888-0094-30 package photo

Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet, 30-count

by Advagen Pharma Ltd · 30 TABLET in 1 BOTTLE (72888-094-30)
NDC 72888-0094-30
🏷️ FDA NDC (as labeled) 72888-094-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1535/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 72888-094-30
Product NDC 72888-094
11-digit billing NDC 72888009430
RxCUI 310812, 310818
UNII 0J48LPH2TH, WS821Z52LQ
UPC 0372888094014, 0372888094007, 0372888095301, 0372888094052 +4 more
Application # ANDA216211
SPL Set ID a5525a2a-d2c7-411b-9ffc-0cc4fe77f7c7
Established class (EPC) Thiazide Diuretic; Potassium-sparing Diuretic
Physiologic effect Increased Diuresis; Decreased Renal K+ Excretion
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-23
Route ORAL
Dosage form TABLET
Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE
GPI-14 37990002300315
GCN Seq No 008176
GCN 88741
HICL code 003647
Ingredient (HICL) Triamterene/Hydrochlorothiazid
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1L
Therapeutic class — specific (HIC3) Potassium Sparing Diuretics In Combination
AHFS code 24:36.20.00
AHFS class Thiazide Diuretics (24:36)
FDB label name TRIAMTERENE-HCTZ 37.5-25 MG TB
FDB brand name Triamterene-Hydrochlorothiazid
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 72888-094-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72888-0094-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Potassium-sparing Diuretic class.

Pharmacologic class Potassium-sparing Diuretic
Drug family (ATC) Other potassium-sparing agents
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

LabelerAdvagen Pharma Ltd
Application holderRUBICON RESEARCH LTD
FDA applicationANDA216211 (ANDA)
Labeler code72888
First marketedFeb 2022
Product typeHuman Prescription Drug
Portfolio100 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 TRIAMTERENE-HCTZ 37.5-25 MG TB Ingredient Triamterene/Hydrochlorothiazid
📗 Our plain-language guide HelloPharmacist
  • Great question. Hydrochlorothiazide on its own works well for blood pressure and fluid retention, but it tends to flush out potassium along with the water — and low potassium can c...
  • Why am I on this combination instead of just a regular water pill?
  • Most people notice things like mild nausea, dizziness, headache, or muscle cramps, especially early on. You might also feel more tired or notice your urine looks a different color...
  • What side effects should I actually watch out for day to day?
📖 Read our full Triamterene and Hydrochlorothiazide guide →
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
ShapeOval
ImprintUpArrowhead;134
Size11 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 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 $0.1535 $4.61 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68001-0387-00 BluePoint 100 tablets $0.091 AB Discontinued
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 00591-0424-01 Actavis 100 tablets $0.098 Availability likely
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 60505-2656-01 Apotex 100 tablets $0.098 AB Availability likely
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68001-0327-00 BluePoint 100 tablets $0.098 AB Availability likely
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68084-0750-25 American 30 tablets $0.098 AB Availability likely
triamterene and hydrochlorothiazide 37.5 mg/1; 25 mg 68382-0856-01 Zydus 100 tablets $0.098 AB Availability likely
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-1270-00 A-S 30 tablets AB FDA listed
triamterene and hydrochlorothiazide 37.5 mg/1; 25 mg 50090-5801-00 A-S 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 51407-0286-01 Golden 100 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 51655-0630-26 Northwind 90 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 55289-0090-15 PD-Rx 15 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-1834-01 NuCare 100 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-2371-09 NuCare 90 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68788-7526-01 Preferred 100 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 70518-1662-00 REMEDYREPACK 30 tablets AB FDA listed
triamterene and hydrochlorothiazide 37.5 mg/1; 25 mg 70771-1361-00 Zydus 1000 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-0356-01 Bryant 30 tablets AB Discontinued
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-0968-01 Bryant 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-2631-01 Bryant 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-2806-01 Bryant 100 tablets AB FDA listed
triamterene and hydrochlorothiazide 37.5 mg/1; 25 mg 71610-0602-60 Aphena 90 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71610-0605-60 Aphena 90 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71610-0684-60 Aphena 90 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 72789-0183-30 PD-Rx 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mgthis 72888-0094-30 Advagen 30 tablets AB FDA listed
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 82868-0006-30 Northwind 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

🏛️
2022
On the market since
Feb 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.

💊 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.
500 tablets72888-0094-05 6,688 Rx · $72,056
100 tablets72888-0094-01 5,479 Rx · $59,267
1000 tablets72888-0094-00 No Medicaid data
Drug total (last 4 qtrs): 12,167 Rx · 470,523 units · $131,323 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Triamterene and Hydrochlorothiazide — the ingredient across all brands.

Top reported reactions

Nausea407
Fatigue399
Pain327
Dizziness318
Diarrhoea309
Headache290
Dyspnoea286

Age at onset

Neonate1
Infant1
Adult323
Elderly337

Reporter sex

6,113 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization1,569
Life-threatening160
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 187 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72888-0094-00 1000 TABLET in 1 BOTTLE (72888-094-00) 2022-02-23 Active
72888-0094-01 100 TABLET in 1 BOTTLE (72888-094-01) $0.0983 / ea $9.83 2022-02-23 Active
72888-0094-05 500 TABLET in 1 BOTTLE (72888-094-05) $0.0983 / ea $49.14 2022-02-23 Active
72888-0094-30 You're viewing this 30 TABLET in 1 BOTTLE (72888-094-30) 2022-02-23 Active

You're viewing the smallest of 4 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 500 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 72888-0094-30?
NDC 72888-0094-30 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 72888-0094-30 and NDC 72888-0094-01?
Both are Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet — the drug itself is identical. NDC 72888-0094-30 is the 30-count package, while NDC 72888-0094-01 is the 100 tablets package.
What NDC number is used to bill for this package of Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet?
Bill NDC 72888-0094-30 — the 11-digit billing format is 72888009430. 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.

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72888-094-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72888-0094-30, written without dashes as 72888009430. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72888-0094-30, the first segment (72888) is the labeler code FDA assigned to Advagen Pharma Ltd; the middle segment (0094) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advagen Pharma Ltd. 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 3 other package presentations of this same product, including 100 tablets (72888-0094-01), 500 tablets (72888-0094-05), 1000 tablets (72888-0094-00). 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?
Advagen Pharma Ltd is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 86 words

WARNINGS: Hyperkalemia: Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment), or elderly or severely ill patients. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide, when dosages are changed or with any illness that may influence renal function.

🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE: This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).

Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard.

Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy.

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 which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which 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 which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION: The usual dose of triamterene and hydrochlorothiazide tablets 37.5mg/25mg is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS ). The usual dose of triamterene and hydrochlorothiazide tablets 75mg/ 50 mg is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS ). There is no experience with the use of more than one triamterene and hydrochlorothiazide tablet 75mg/50mg daily or more than two triamterene and hydrochlorothiazide tablets 37.5mg/25mg daily.

Clinical experience with the administration of two triamterene and hydrochlorothiazide tablets 37.5mg/25mg daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction. Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets 75mg/50mg directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets 37.5mg/25mg directly.

In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked therapy may be initiated with triamterene and hydrochlorothiazide tablets 37.5mg/25mg. If an optimal blood pressure response is not obtained with triamterene and hydrochlorothiazide tablets 37.5mg/25mg, the dose should be increased to two triamterene and hydrochlorothiazide tablets 37.5mg/25mg daily as a single dose, or one triamterene and hydrochlorothiazide tablet 75mg/25mg daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS: Drug Interactions ).

Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one triamterene and hydrochlorothiazide tablets 37.5mg/25mg daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets 75mg/50mg should be monitored clinically and for serum potassium after the transfer.

Contraindications 128 words

CONTRAINDICATIONS: Hyperkalemia: Triamterene and hydrochlorothiazide should not be used in the presence of elevated serum potassium levels (greater than or equal to 5.5 mEq/liter). If hyperkalemia develops, this drug should be discontinued and a thiazide alone should be substituted. Antikaliuretic Therapy or Potassium Supplementation: Triamterene and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents such as spironolactone, amiloride hydrochloride or other formulations containing triamterene.

Concomitant potassium supplementation in the form of medication, potassium-containing salt substitute or potassium-enriched diets should also not be used. Impaired Renal Function: Triamterene and hydrochlorothiazide is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment. Hypersensitivity: Triamterene and hydrochlorothiazide should not be used in patients who are hypersensitive to triamterene or hydrochlorothiazide or other sulfonamide-derived drugs.

⚠️ Warnings ~2 min read

WARNINGS: Hyperkalemia: Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment), or elderly or severely ill patients. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide, when dosages are changed or with any illness that may influence renal function.

If hyperkalemia is suspected, (warning signs include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia and shock) an electrocardiogram (ECG) should be obtained. However, it is important to monitor serum potassium levels because mild hyperkalemia may not be associated with ECG changes. If hyperkalemia is present, triamterene and hydrochlorothiazide should be discontinued immediately and a thiazide alone should be substituted.

If the serum potassium exceeds 6.5 mEq/liter, more vigorous therapy is required. The clinical situation dictates the procedures to be employed. These include the intravenous administration of calcium chloride solution, sodium bicarbonate solution and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation.

Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis. The development of hyperkalemia associated with potassium-sparing diuretics is accentuated in the presence of renal impairment (see CONTRAINDICATIONS ).

Patients with mild renal functional impairment should not receive this drug without frequent and continuing monitoring of serum electrolytes. Cumulative drug effects may be observed in patients with impaired renal function. The renal clearances of hydrochlorothiazide and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following triamterene and hydrochlorothiazide administration to elderly patients and patients with impaired renal function.

Hyperkalemia has been reported in diabetic patients with the use of potassium-conserving agents even in the absence of apparent renal impairment. Accordingly, triamterene and hydrochlorothiazide should be avoided in diabetic patients. If it is employed, serum electrolytes must be frequently monitored.

Because of the potassium-sparing properties of angiotensin-converting enzyme (ACE) inhibitors, triamterene and hydrochlorothiazide should be used cautiously, if at all, with these agents (see PRECAUTIONS: Drug Interactions ). Metabolic or Respiratory Acidosis: Potassium-conserving therapy should also be avoided in severely ill patients in whom respiratory or metabolic acidosis may occur. Acidosis may be associated with rapid elevations in serum potassium levels.

If triamterene and hydrochlorothiazide is employed, frequent evaluations of acid/base balance and serum electrolytes are necessary. Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.

Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.

Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS: Side effects observed in association with the use of triamterene and hydrochlorothiazide, other combination products containing triamterene/hydrochlorothiazide, and products containing triamterene or hydrochlorothiazide include the following: Gastrointestinal: jaundice (intrahepatic cholestatic jaundice), pancreatitis, nausea, appetite disturbance, taste alteration, vomiting, diarrhea, constipation, anorexia, gastric irritation, cramping. Central Nervous System: drowsiness and fatigue, insomnia, headache, dizziness, dry mouth, depression, anxiety, vertigo, restlessness, paresthesias.

Cardiovascular: tachycardia, shortness of breath and chest pain, orthostatic hypotension (may be aggravated by alcohol, barbiturates or narcotics). Renal: acute renal failure, acute interstitial nephritis, renal stones composed of triamterene in association with other calculus materials, urine discoloration. Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia and megaloblastosis.

Ophthalmic: xanthopsia, transient blurred vision. Hypersensitivity: anaphylaxis, photosensitivity, rash, urticaria, purpura, necrotizing angiitis (vasculitis, cutaneous vasculitis), fever, respiratory distress including pneumonitis. Other: muscle cramps and weakness, decreased sexual performance and sialadenitis.

Whenever adverse reactions are moderate to severe, therapy should be reduced or withdrawn. Altered Laboratory Findings: Serum Electrolytes: hyperkalemia, hypokalemia, hyponatremia, hypomagnesemia, hypochloremia (see WARNINGS and PRECAUTIONS ). Creatinine, Blood Urea Nitrogen: Reversible elevations in BUN and serum creatinine have been observed in hypertensive patients treated with triamterene and hydrochlorothiazide.

Glucose: hyperglycemia, glycosuria and diabetes mellitus (see PRECAUTIONS ). Serum Uric Acid, PBI and Calcium: (see PRECAUTIONS ). Other: Elevated liver enzymes have been reported in patients receiving triamterene and hydrochlorothiazide.

Postmarketing Experience: Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥ 50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

🔄 Drug Interactions 145 words

Drug Interactions: Thiazides may add to or potentiate the action of other antihypertensive drugs. The thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Thiazides have also been shown to increase the responsiveness to tubocurarine. Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Refer to the package insert on lithium before use of such concomitant therapy.

Acute renal failure has been reported in a few patients receiving indomethacin and formulations containing triamterene and hydrochlorothiazide. Caution is therefore advised when administering non-steroidal anti-inflammatory agents with triamterene and hydrochlorothiazide. Potassium-sparing agents should be used very cautiously, if at all, in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to a greatly increased risk of hyperkalemia.

Serum potassium should be monitored frequently.

🧒 Pediatric Use 34 words

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Information for Patients: Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

🆘 Overdosage 105 words

OVERDOSAGE: No specific data are available regarding triamterene and hydrochlorothiazide overdosage in humans and no specific antidote is available. Fluid and electrolyte imbalances are the most important concern. Excessive doses of the triamterene component may elicit hyperkalemia, dehydration, nausea, vomiting and weakness and possibly hypotension.

Overdosing with hydrochlorothiazide has been associated with hypokalemia, hypochloremia, hyponatremia, dehydration, lethargy (may progress to coma) and gastrointestinal irritation. Treatment is symptomatic and supportive. Therapy with triamterene and hydrochlorothiazide should be discontinued.

Induce emesis or institute gastric lavage. Monitor serum electrolyte levels and fluid balance. Institute supportive measures as required to maintain hydration, electrolyte balance, respiratory, cardiovascular and renal function.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY: Triamterene and hydrochlorothiazide tablets are diuretic, antihypertensive drug product, principally due to its hydrochlorothiazide component; the triamterene component of triamterene and hydrochlorothiazide tablets reduces the excessive potassium loss which may occur with hydrochlorothiazide use. Hydrochlorothiazide: Hydrochlorothiazide is a diuretic and antihypertensive agent. It blocks the renal tubular absorption of sodium and chloride ions.

This natriuresis and diuresis is accompanied by a secondary loss of potassium and bicarbonate. Onset of hydrochlorothiazide’s diuretic effect occurs within 2 hours and the peak action takes place in 4 hours. Diuretic activity persists for approximately 6 to 12 hours.

The exact mechanism of hydrochlorothiazide’s antihypertensive action is not known although it may relate to the excretion and redistribution of body sodium. Hydrochlorothiazide does not affect normal blood pressure. Following oral administration, peak hydrochlorothiazide plasma levels are attained in approximately 2 hours.

It is excreted rapidly and unchanged in the urine. Well controlled studies have demonstrated that doses of hydrochlorothiazide as low as 25 mg given once daily are effective in treating hypertension, but the dose-response has not been clearly established. Triamterene: Triamterene is a potassium-conserving (antikaliuretic) diuretic with relatively weak natriuretic properties.

It exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen. With this action, triamterene increases sodium excretion and reduces the excessive loss of potassium and hydrogen associated with hydrochlorothiazide. Triamterene is not a competitive antagonist of the mineralocorticoids and its potassium-conserving effect is observed in patients with Addison’s disease, i.e., without aldosterone.

Triamterene’s onset and duration of activity is similar to hydrochlorothiazide. No predictable antihypertensive effect has been demonstrated with triamterene. Triamterene is rapidly absorbed following oral administration.

Peak plasma levels are achieved within one hour after dosing. Triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene. Both the plasma and urine levels of this metabolite greatly exceed triamterene levels.

The amount of triamterene added to 50 mg of hydrochlorothiazide in triamterene and hydrochlorothiazide 75mg/50mg tablets was determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (50 mg given once daily). Single daily doses of 75 mg triamterene resulted in greater increases in serum potassium than lower doses (25 mg and 50 mg), while doses greater than 75 mg of triamterene resulted in no additional elevations in serum potassium levels.

The amount of triamterene added to the 25 mg of hydrochlorothiazide in triamterene and hydrochlorothiazide 37.5mg/25mg tablets was also determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (25 mg given once daily). Single daily doses of 37.5 mg triamterene resulted in greater increases in serum potassium than a lower dose (25 mg), while doses greater than 37.5 mg of triamterene, i.e., 75 mg and 100 mg, resulted in no additional elevations in serum potassium levels.

The dose-response relationship of triamterene was also evaluated in patients rendered hypokalemic by hydrochlorothiazide given 25 mg twice daily. Triamterene given twice daily increased serum potassium levels in a dose related fashion. However, the combination of triamterene and hydrochlorothiazide given twice daily also appeared to produce an increased frequency of elevation in serum BUN and creatinine level…

📦 How Supplied / Storage and Handling 182 words

HOW SUPPLIED: Triamterene and hydrochlorothiazide tablets, USP 75mg/50 mg are yellow colored, oval shaped tablets, debossed with “Λ 135” one side and scored on the other side. Each tablet contains 75 mg of triamterene, USP and 50 mg of hydrochlorothiazide, USP. They are supplied as follows: NDC 72888-095-30 bottle of 30 NDC 72888-095-01 bottles of 100 NDC 72888-095-05 bottles of 500 NDC 72888-095-00 bottles of 1000 Triamterene and hydrochlorothiazide tablets, USP 37.5mg/25 mg are yellow colored, oval shaped tablets, debossed with “Λ 134” one side and scored on the other side.

Each tablet contains 37.5 mg of triamterene, USP and 25 mg of hydrochlorothiazide, USP. They are supplied as follows: NDC 72888-094-30 bottle of 30 NDC 72888-094-01 bottles of 100 NDC 72888-094-05 bottles of 500 NDC 72888-094-00 bottles of 1000 Store at 20º to 25ºC (68º to 77ºF) [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.

Manufactured by: Rubicon Research Ltd., Thane 421506, India. Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA. Rev.

01/2026

📋 Description 176 words

DESCRIPTION: Triamterene and hydrochlorothiazide tablets, USP combine triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and hydrochlorothiazide tablet, USP contains: Triamterene, USP ............................................................................... 75 mg Hydrochlorothiazide, USP ..................................................................

50 mg OR Triamterene, USP ................................................................................ 37.5 mg Hydrochlorothiazide, USP .................................................................. 25 mg Triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No.

10 Aluminum Lake, Hypromellose, magnesium stearate and microcrystalline cellulose. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides.

It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27.

Its structural formula is: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4,benzothiadiazine-7- sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids.

Its molecular weight is 297.73. Its structural formula is: Triamterene Structural Formula Hydrochlorothiazide Structural Formula

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.