NDC 82868-0022-30 — Triamterene and Hydrochlorothiazide 37.5 mg;

🆔 Identity & classification

FDA NDC (as labeled) 82868-022-30

Product NDC 82868-022

11-digit billing NDC 82868002230

RxCUI 198316

UNII WS821Z52LQ, 0J48LPH2TH

Application # ANDA208358

SPL Set ID 08f3885e-dfde-79e4-e063-6394a90a4c09

Established class (EPC) Potassium-sparing Diuretic; Thiazide Diuretic

Physiologic effect Decreased Renal K+ Excretion; Increased Diuresis

Chemical class Thiazides

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-10-24

Route ORAL

Dosage form CAPSULE

Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 82868-022-30 — 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 → 82868-0022-30. 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

LabelerNorthwind Health Company, LLC

Application holderCADILA HEALTHCARE LTD

FDA applicationANDA208358 (ANDA)

Labeler code82868

First marketedOct 2023

Product typeHuman Prescription Drug

Portfolio578 products on file

🔎 All NDCs from Northwind Health Company, LLC

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

📖 What it is MedlinePlus · NLM

The combination of triamterene and hydrochlorothiazide is used to treat high blood pressure and edema (fluid retention; excess fluid held in body tissues) in patients who have lower amounts of potassium in their bodies or for whom low potassium levels in the body could be dangerous. The combination of triamterene and hydrochlorothiazide is in a class of medications called diuretics ('water pills'). They work by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition, and when not treated it can cause damage to the brain,...

Read the full MedlinePlus article ↗

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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

ShapeCapsule

Imprint855

Size14 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
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 WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 system	Per each	Per 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 00781-2074-01	Sandoz	100 capsules	$0.122	AB	Availability likely	—
Triamterene And Hydrochlorothiazide 37.5 mg/1; 25 mg 62135-0529-90	Chartwell	90 capsules	$0.122	AB	Availability likely	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 72578-0090-01	Viona	100 capsules	$0.122	AB	Availability likely	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 33342-0467-11	Macleods	100 capsules	—	—	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-2028-00	A-S	30 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-6944-00	A-S	90 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-7437-00	A-S	30 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 50090-7438-00	A-S	90 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 51655-0722-52	Northwind	30 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 60760-0783-90	St.	90 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 63187-0465-30	Proficient	30 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 63187-0905-30	Proficient	30 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 63629-8732-01	Bryant	100 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-2533-09	NuCare	90 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-3879-09	NuCare	90 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68382-0855-01	Zydus	100 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68788-8700-01	Preferred	100 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 70518-4270-00	REMEDYREPACK	90 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 70771-1474-00	Zydus	1000 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-0504-01	Bryant	100 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-2034-01	Bryant	100 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 72162-1084-06	Bryant	60 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mgthis 82868-0022-30	Northwind	30 capsules	—	AB	FDA listed	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 82804-0308-30	Proficient	30 capsules	—	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

🏛️

2023

On the market since

Oct 2023

📍

2026

Currently FDA-listed

3 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.

🔬 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

Male · 27%

Female · 73%

Unknown · 0%

Serious outcomes

Hospitalization1,569

Life-threatening160

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
82868-0022-30 You're viewing this	30 CAPSULE in 1 BOTTLE, PLASTIC (82868-022-30)	2023-10-24	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 82868-022-30, 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: 82868-0022-30, written without dashes as 82868002230. 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 82868-0022-30, the first segment (82868) is the labeler code FDA assigned to Northwind Health Company, LLC; the middle segment (0022) 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 Northwind Health Company, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Northwind Health Company, LLC 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 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🚨 Boxed Warning 89 words ▾

Hyperkalemia Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including triamterene and hydrochlorothiazide capsules. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment) and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide capsules, 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 capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

Triamterene and hydrochlorothiazide capsules may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules may enhance the action of these agents, 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. Diuretics 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 36 words ▾

DOSAGE AND ADMINISTRATION The usual dose of triamterene and hydrochlorothiazide capsules is 1 or 2 capsules given once daily , with appropriate monitoring of serum potassium and of the clinical effect ( see WARNINGS, Hyperkalemia ).

⛔ Contraindications 137 words ▾

CONTRAINDICATIONS Antikaliuretic Therapy and Potassium Supplementation Triamterene and hydrochlorothiazide capsules should not be given to patients receiving other potassium-sparing agents such as spironolactone, amiloride, or other formulations containing triamterene. Concomitant potassium-containing salt substitutes should also not be used. Potassium supplementation should not be used with triamterene and hydrochlorothiazide capsules except in severe cases of hypokalemia.

Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary. Impaired Renal Function Triamterene and hydrochlorothiazide capsules are contraindicated in patients with anuria, acute and chronic renal insufficiency, or significant renal impairment.

Hypersensitivity Hypersensitivity to either drug in the preparation or to other sulfonamide-derived drugs is a contraindication. Hyperkalemia Triamterene and hydrochlorothiazide capsules should not be used in patients with pre-existing elevated serum potassium. WARNINGS

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Adverse effects are listed in decreasing order of severity. Hypersensitivity: Anaphylaxis, rash, urticaria, subacute cutaneous lupus erythematosus-like reactions, photosensitivity. Cardiovascular: Arrhythmia, postural hypotension.

Metabolic: Diabetes mellitus, hyperkalemia, hypokalemia, hyponatremia, acidosis, hypercalcemia, hyperglycemia, glycosuria, hyperuricemia, hypochloremia. Gastrointestinal: Jaundice and/or liver enzyme abnormalities, pancreatitis, nausea and vomiting, diarrhea, constipation, abdominal pain. Renal: Acute renal failure (one case of irreversible renal failure has been reported), interstitial nephritis, renal stones composed primarily of triamterene, elevated BUN and serum creatinine, abnormal urinary sediment.

Hematologic: Leukopenia, thrombocytopenia and purpura, megaloblastic anemia. Musculoskeletal: Muscle cramps. Central Nervous System: Weakness, fatigue, dizziness, headache, dry mouth.

Miscellaneous: Impotence, sialadenitis. Thiazides alone have been shown to cause the following additional adverse reactions: Central Nervous System: Paresthesias, vertigo. Ophthalmic: Xanthopsia, transient blurred vision.

Respiratory: Allergic pneumonitis, pulmonary edema, respiratory distress. Other: Necrotizing vasculitis, exacerbation of lupus. Hematologic: Aplastic anemia, agranulocytosis, hemolytic anemia.

Neonate and infancy: Thrombocytopenia and pancreatitis–rarely, in newborns whose mothers have received thiazides during pregnancy. Skin: Erythema multiforme, including Stevens-Johnson syndrome; exfoliative dermatitis, including toxic epidermal necrolysis. 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. To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

Drug Interactions Angiotensin-Converting Enzyme Inhibitors Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia. Oral Hypoglycemic Drugs Concurrent use with chlorpropamide may increase the risk of severe hyponatremia. Nonsteroidal Anti-inflammatory Drugs A possible interaction resulting in acute renal failure has been reported in a few patients on triamterene and hydrochlorothiazide capsules when treated with indomethacin, a nonsteroidal anti-inflammatory agent.

Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene and hydrochlorothiazide capsules. Lithium Lithium generally should not be given with diuretics because they reduce its renal clearance and increase the risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy with triamterene and hydrochlorothiazide capsules.

Surgical Considerations Thiazides have been shown to decrease arterial responsiveness to norepinephrine (an effect attributed to loss of sodium). This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the paralyzing effect of nondepolarizing muscle relaxants such as tubocurarine (an effect attributed to potassium loss); consequently, caution should be observed in patients undergoing surgery Other Considerations Concurrent use of hydrochlorothiazide with amphotericin B or corticosteroids or corticotropin (ACTH) may intensify electrolyte imbalance, particularly hypokalemia, although the presence of triamterene minimizes the hypokalemic effect.

Thiazides may add to or potentiate the action of other antihypertensive drugs. See INDICATIONS AND USAGE for concomitant use with other antihypertensive drugs. The effect of oral anticoagulants may be decreased when used concurrently with hydrochlorothiazide; dosage adjustments may be necessary.

Triamterene and hydrochlorothiazide may raise the level of blood uric acid; dosage adjustments of antigout medication may be necessary to control hyperuricemia and gout. The following agents given together with triamterene may promote serum potassium accumulation and possibly result in hyperkalemia because of the potassium-sparing nature of triamterene, especially in patients with renal insufficiency: blood from blood bank (may contain potassium up to 30 mEq/L of plasma or up to 65 mEq/L of whole blood when stored for more than 10 days); low-salt milk (may contain potassium up to 60 mEq/L); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).

Exchange resins, such as sodium polystyrene sulfonate, whether administered orally or rectally, reduce serum potassium levels by sodium replacement of the potassium; fluid retention may occur in some patients because of the increased sodium intake. Chronic or overuse of laxatives may reduce serum potassium levels by promoting excessive potassium loss from the intestinal tract; laxatives may interfere with the potassium-retaining effects of triamterene. The effectiveness of methenamine may be decreased when used concurrently with hydrochlorothiazide because of alkalinization of the urine.

🤰 Pregnancy ~2 min read ▾

Pregnancy Teratogenic Effects Triamterene and Hydrochlorothiazide : Animal reproduction studies to determine the potential for fetal harm by triamterene and hydrochlorothiazide have not been conducted. However, a One Generation Study in the rat approximated composition of triamterene and hydrochlorothiazide capsules by using a 1:1 ratio of triamterene to hydrochlorothiazide (30:30 mg/kg/day); there was no evidence of teratogenicity at those doses which were, on a body-weight basis, 15 and 30 times, respectively, the MRHD, and on the basis of body surface area, 3.1 and 6.2 times, respectively, the MRHD.

The safe use of triamterene and hydrochlorothiazide capsules in pregnancy has not been established since there are no adequate and well-controlled studies with triamterene and hydrochlorothiazide in pregnant women. Triamterene and hydrochlorothiazide capsules should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Triamterene: Reproduction studies have been performed in rats at doses as high as 20 times the MRHD on the basis of body weight and 6 times the human dose on the basis of body surface area without evidence of harm to the fetus due to triamterene.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Hydrochlorothiazide: Hydrochlorothiazide was orally administered to pregnant mice and rats during respective periods of major organogenesis at doses up to 3,000 and 1,000 mg/kg/day, respectively. At these doses, which are multiples of the MRHD equal to 3,000 for mice and 1,000 for rats, based on body weight, and equal to 282 for mice and 206 for rats, based on body surface area, there was no evidence of harm to the fetus.

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 and triamterene have been shown to cross the placental barrier and appear in cord blood.

The use of thiazides and triamterene in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possible other adverse reactions which have occurred in the adult.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 111 words ▾

OVERDOSAGE Electrolyte imbalance is the major concern (see WARNINGS ). Symptoms reported include: polyuria, nausea, vomiting, weakness, lassitude, fever, flushed face, and hyperactive deep tendon reflexes. If hypotension occurs, it may be treated with pressor agents such as levarterenol to maintain blood pressure.

Carefully evaluate the electrolyte pattern and fluid balance. Induce immediate evacuation of the stomach through emesis or gastric lavage. There is no specific antidote.

Reversible acute renal failure following ingestion of 50 tablets of a product containing a combination of 50 mg triamterene and 25 mg hydrochlorothiazide has been reported. Although triamterene is largely protein-bound (approximately 67%), there may be some benefit to dialysis in cases of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Triamterene and hydrochlorothiazide capsule is a diuretic/antihypertensive drug product that combines natriuretic and antikaliuretic effects. Each component complements the action of the other. The hydrochlorothiazide component blocks the reabsorption of sodium and chloride ions, and thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted.

A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen, and chloride ions. Hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide, and may reduce glomerular filtration rate.

The exact mechanism of the antihypertensive effect of hydrochlorothiazide is not known. The triamterene component of triamterene and hydrochlorothiazide capsules exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen ions. Its natriuretic activity is limited by the amount of sodium reaching its site of action.

Although it blocks the increase in this exchange that is stimulated by mineralocorticoids (chiefly aldosterone), it is not a competitive antagonist of aldosterone and its activity can be demonstrated in adrenalectomized rats and patients with Addison's disease. As a result, the dose of triamterene required is not proportionally related to the level of mineralocorticoid activity but is dictated by the response of the individual patients and the kaliuretic effect of concomitantly administered drugs. By inhibiting the distal tubular exchange mechanism, triamterene maintains or increases the sodium excretion and reduces the excess loss of potassium, hydrogen, and chloride ions induced by hydrochlorothiazide.

As with hydrochlorothiazide, triamterene may reduce glomerular filtration and renal plasma flow. Via this mechanism, it may reduce uric acid excretion although it has no tubular effect on uric acid reabsorption or secretion. Triamterene does not affect calcium excretion.

No predictable antihypertensive effect has been demonstrated for triamterene. Duration of diuretic activity and effective dosage range of the hydrochlorothiazide and triamterene components of triamterene and hydrochlorothiazide capsules are similar. Onset of diuresis with triamterene and hydrochlorothiazide takes place within 1 hour, peaks at 2 to 3 hours, and tapers off during the subsequent 7 to 9 hours.

Triamterene and hydrochlorothiazide capsules are well absorbed. Upon administration of a single oral dose to fasted normal male volunteers, mean pharmacokinetic parameters were determined (Table 1). Table 1.

Mean Pharmacokinetic Parameters after Single Oral Dose in Fasted Male Volunteers a AUC (0-48) ng*h/mL (± SD) C max ng/mL (± SD) Median T max h Ae Mg (± SD) Triamterene 148.7 (87.9) 46.4 (29.4) 1.1 2.7 (1.4) Hydroxytriamterene sulfate 1,865 (471) 720 (364) 1.3 19.7 (6.1) Hydrochlorothiazide 834 (177) 135.1 (35.7) 2 14.3 (3.8) a AUC (0-48) , C max , T max, and Ae represent area under the plasma concentration versus time plot, maximum plasma concentration, time to reach C max , and amount excreted in urine over 48 hours.

A capsule of triamterene and hydrochlorothiazide is bioequivalent to a single entity 25-mg hydrochlorothiazide tablet and 37.5-mg triamterene capsule used in the double-blind clinical trial below ( see Clinical Trials ). In a limited study involving 12 subjects, coadministration of triamterene and hydrochlorothiazide capsules with a high-fat meal resulted in: (1) an increase in the mean bioavailability of triamterene by about 67% (90% confidence interval = 0.99, 1.90), p-hydroxytriamterene sulfate by about 50% (90% confidence interval = 1.06, 1.77), hydrochlorothiazide by about 17% (90% confidenc…

📦 How Supplied / Storage and Handling 114 words ▾

HOW SUPPLIED Triamterene and Hydrochlorothiazide Capsules USP, 37.5 mg/25 mg are light yellow to yellow colored powder filled in size '4' empty hard gelatin capsule having yellow opaque colored cap imprinted with "855" in black ink and white opaque colored body and are supplied as follows: NDC 82868-022-30 in bottles of 30 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Zydus Lifesciences Ltd., India Distributed by: Viona Pharmaceuticals Inc.

Cranford, NJ 07016 Rev.: 10/22

📋 Description ~1 min read ▾

DESCRIPTION Each capsule of triamterene and hydrochlorothiazide for oral use, with opaque yellow cap and opaque white body, contains triamterene 37.5 mg and hydrochlorothiazide 25 mg, and is imprinted with 855. Hydrochlorothiazide is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent. Hydrochlorothiazide, USP is very slightly soluble in water.

It is freely soluble in sodium hydroxide solution, n-butylamine and dimethyl formamide. It is sparingly soluble in methanol. It is insoluble in ether, chloroform and dilute mineral acids.

Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H -1, 2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is: Triamterene, USP is soluble in formic acid. It is sparingly soluble in methoxyethanol. It is very slightly soluble in acetic acid, alcohol and dilute mineral acids.

It is practically insoluble in water, benzene, ether, chloroform and dilute alkali hydroxides. Triamterene, USP is 2, 4, 7-triamino-6-phenylpteridine and its structural formula is: Each triamterene and hydrochlorothiazide capsule, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP. In addition, each capsule contains the following inactive ingredients: citric acid monohydrate, colloidal silicon dioxide, croscarmellose sodium, gelatin, glycine, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide.

Each capsule is printed with black pharmaceutical ink which contains ferric oxide black, potassium hydroxide and shellac. Capsules of triamterene and hydrochlorothiazide meet Drug Release Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules. image image

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anuria: Producing little or no urine, which can be a sign of severe kidney problems.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

competitive antagonist: A blocker that competes with another substance for the same docking spot; adding more of the other substance can overcome the block.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

glycosuria: Sugar (glucose) in the urine, which often happens when blood sugar is high.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hypercalcemia: A higher-than-normal level of calcium, a mineral, in the blood.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

urticaria: Raised, itchy welts on the skin, commonly called hives.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

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

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

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