NDC 68382-0856-77 — triamterene and hydrochlorothiazide 37.5 mg; 25 mg

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68382-856-77

Product NDC 68382-856

11-digit billing NDC 68382085677

RxCUI 310812, 310818

UNII 0J48LPH2TH, WS821Z52LQ

UPC 0368382856012, 0368382857019

Application # ANDA208360

SPL Set ID fa69eeb8-ec82-4be1-8cb7-f64094ed957c

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 2018-09-04

Route ORAL

Dosage form TABLET

Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE

TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 37990002300315

GPI class Triamterene-HCTZ

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

Quick answers

GSN (GCN sequence number): 008176
GCN: 88741
GPI-14 (Medi-Span): 37990002300315
HICL (First Databank): 003647
AHFS class code: 24:36.20.00
RxCUI (RxNorm): 310812

Why two NDCs? The FDA registers this code as 68382-856-77 — 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 → 68382-0856-77. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name TRIAMTERENE-HCTZ 37.5-25 MG TB Ingredient Triamterene/Hydrochlorothiazid

📗 Our plain-language guide HelloPharmacist

It treats high blood pressure or fluid swelling (edema). It is mainly for people who lose too much potassium on hydrochlorothiazide alone, or who need a water pill but can't risk l...
Take it by mouth, usually once a day, exactly as your prescriber directs. Don't split the daily dose unless told to. You'll need regular blood tests to check your potassium.
No, not unless your doctor tells you to. Most salt substitutes are full of potassium. With this medicine, they can push your potassium dangerously high.
Can I use salt substitutes or potassium supplements?

📖 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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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 · Q2 2026	$0.1535	$15.35 / 100 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Marketing end	Status
68382-0856-01 68382-856-01 Main listing	100 TABLET in 1 BOTTLE	$0.0969 / ea	$9.69	2018-09-04	—	Active
68382-0856-05 68382-856-05	500 TABLET in 1 BOTTLE	$0.0969 / ea	$48.47	2018-09-04	—	Active
68382-0856-10 68382-856-10	1000 TABLET in 1 BOTTLE	—	—	2018-09-04	—	Active
68382-0856-77 You're viewing this	10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK	—	—	2018-09-04	—	Active

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?

This is a 100-count package — 10 blister pack in 1 carton / 10 tablet in 1 blister pack.

How does this package differ from NDC 68382-0856-01?

Both are triamterene and hydrochlorothiazide 37.5 mg; 25 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 68382-0856-01 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?

Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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	$0.097	—	Availability likely	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 60505-2656-01	Apotex	100 tablets	$0.097	AB	Availability likely	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68001-0327-00	BluePoint	100 tablets	$0.097	AB	Availability likely	—
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68084-0750-25	American	30 tablets	$0.097	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 mgthis 68382-0856-77	Zydus	100 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 mg 72888-0094-00	Advagen	1000 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2018

On the market since

Sep 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.

FDA Orange Book · refreshed Sep 3, 2026

What it looks like

Color Green / Yellow

ShapeRound

Imprint857

Size1 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.

FDA label on DailyMed · label index refreshed Oct 1, 2026

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.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

Manufacturer & labeler

LabelerZydus Pharmaceuticals (USA) Inc.

Application holderZYDUS PHARMACEUTICALS USA INC

FDA applicationANDA208360 (ANDA)

Labeler code68382

First marketedSep 2018

Product typeHuman Prescription Drug

Portfolio173 products on file

🔎 All NDCs from Zydus Pharmaceuticals (USA) Inc.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🚨 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 ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel

🚨 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 ~2 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 tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide tablets, USP are 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 tablets, USP may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets, USP 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 ~2 min read ▾

DOSAGE AND ADMINISTRATION The usual dose of triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg 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, 75 mg/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 75 mg/50 mg (75 mg triamterene and 50 mg hydrochlorothiazide) tablet daily or more than two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily.

Clinical experience with the administration of two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets 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, 75 mg/50 mg directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg directly.

In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked therapy may be initiated with triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg. If an optimal blood pressure response is not obtained with triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg, the dose should be increased to two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily as a single dose, or one triamterene and hydrochlorothiazide tablets, 75 mg/50 mg 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, 37.5 mg/25 mg daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets, 75 mg/50 mg 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.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Side effects observed in association with the use of triamterene and hydrochlorothiazide tablets, 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.

🤰 Pregnancy ~1 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. Nevertheless, a One Generation Study in the rat approximated triamterene and hydrochlorothiazide's composition by using a 1:1 ratio of triamterene to hydrochlorothiazide (30:30 mg/kg/day). There was no evidence of teratogenicity at those doses that 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 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 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 Maximum Recommended Human Dose (MRHD) on the basis of body-weight, and 6 times the MRHD 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 3000 and 1000 mg/kg/day, respectively. At these doses, which are multiples of the MRHD equal to 3000 for mice and 1000 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.

🧒 Pediatric Use 12 words ▾

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

🆘 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 ~3 min read ▾

CLINICAL PHARMACOLOGY Triamterene and hydrochlorothiazide is a diuretic, antihypertensive drug product, principally due to its hydrochlorothiazide component; the triamterene component of triamterene and hydrochlorothiazide 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 tablets, 75 mg/50 mg 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 tablets, 37.5 mg/25 mg 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 levels.

The large… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 216 words ▾

HOW SUPPLIED Triamterene and Hydrochlorothiazide Tablets USP, 37.5 mg/25 mg are yellowish green to green colored, spotted, round shaped, flat, uncoated tablets debossed with '856' on one side and breakline on the other side and are supplied as follows: NDC 68382-856-01 in bottles of 100 tablets with child-resistant closure NDC 68382-856-05 in bottles of 500 tablets NDC 68382-856-10 in bottles of 1000 tablets NDC 68382-856-77 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Triamterene and Hydrochlorothiazide Tablets USP, 75 mg/50 mg are light yellow to yellow colored, round shaped, flat, uncoated tablets debossed with '857' on one side and breakline on the other side and are supplied as follows: NDC 68382-857-01 in bottles of 100 tablets with child-resistant closure NDC 68382-857-05 in bottles of 500 tablets NDC 68382-857-10 in bottles of 1000 tablets NDC 68382-857-77 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Store at 20º to 25º C (68º to 77º 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., Matoda, Ahmedabad, India Distributed by: Zydus Pharmaceuticals ( USA) Inc. Pennington, NJ 08534 Rev.: 11/22

📋 Description ~1 min read ▾

DESCRIPTION Triamterene and hydrochlorothiazide combines triamterene a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg contains: Triamterene, USP ..............................................................................37.5 mg Hydrochlorothiazide, USP ................................................................25 mg Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg contains: Triamterene, USP .............................................................................75 mg Hydrochlorothiazide, USP ................................................................50 mg Each triamterene and hydrochlorothiazide tablet, USP intended for oral administration contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP and 75 mg triamterene USP with 50 mg hydrochlorothiazide USP.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and microcrystalline cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue No.

1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. 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.

Its molecular weight is 253.26. Its structural formula is: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. 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.

Its molecular weight is 297.7. Its structural formula is: figure figure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Electrolyte Imbalance and BUN Increases Patients receiving triamterene and hydrochlorothiazide should be carefully monitored for fluid or electrolyte imbalances, i.e., hyponatremia, hypochloremic alkalosis, hypokalemia and hypomagnesemia. Determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. Serum and urine electrolyte determinations are especially important and should be frequently performed when the patient is vomiting or receiving parenteral fluids.

Warning signs or symptoms of fluid and electrolyte imbalance include: 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. Any chloride deficit during thiazide therapy is generally mild and usually does not require any 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. Hypokalemia may develop with thiazide therapy, especially with brisk diuresis, when severe cirrhosis is present, or during concomitant use of corticosteroids, ACTH, amphotericin B or after prolonged thiazide therapy. However, hypokalemia of this type is usually prevented by the triamterene component of triamterene and hydrochlorothiazide.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Triamterene and hydrochlorothiazide may produce an elevated blood urea nitrogen level (BUN), creatinine level or both.

This is probably not the result of renal toxicity but is secondary to a reversible reduction of the glomerular filtration rate or a depletion of the intravascular fluid volume. Elevations in BUN and creatinine levels may be more frequent in patients receiving divided dose diuretic therapy. Periodic BUN and creatinine determinations should be made especially in elderly patients, patients with suspected or confirmed hepatic disease or renal insufficiencies.

If azotemia increases, triamterene and hydrochlorothiazide should be discontinued. Hepatic Coma Triamterene and hydrochlorothiazide 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. Renal Stones Triamterene has been reported in renal stones in association with other calculus components.

Triamterene and hydrochlorothiazide should be used with caution in patients with histories of renal lithiasis. Folic Acid Deficiency Triamterene is a weak folic acid antagonist and may contribute to the appearance of megaloblastosis in instances where folic acid stores are decreased. In such patients, periodic blood elevations are recommended.

Hyperuricemia Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. Metabolic and Endocrine Effects The thiazides may decrease serum PBI levels without signs of thyroid disturbance. Calcium excretion is decreased by thiazides.

Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen. Thiazides should be discontinued before carrying out tests for parathyroid function.

Insulin requirements in diabetic patients may be increased, decreased or unchanged. Diabetes mellitus which… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 47 words ▾

Nursing Mothers Thiazides and triamterene in combination have not been studied in nursing mothers. Triamterene appears in animal milk and this may occur in humans. Thiazides are excreted in human breast milk. If use of the combination drug product is deemed essential, the patient should stop nursing.

📄 Package Label / Principal Display Panel 36 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-856-01 Triamterene and Hydrochlorothiazide Tablets USP, 37.5 mg/25 mg 100 Tablets Rx only Zydus NDC 68382-857-01 Triamterene and Hydrochlorothiazide Tablets USP, 75 mg/50 mg 100 Tablets Rx only Zydus figure figure

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.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

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.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

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.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

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

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

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

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.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

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

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.

depression: A lasting low mood with loss of interest that affects everyday life.

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.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

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.

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

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.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

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

hypophosphatemia: A lower-than-normal level of phosphate, a mineral, 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.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

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

irritability: Getting annoyed, frustrated, or angry more easily than usual.

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

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

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

metabolite: A new substance formed when the body breaks a medicine down.

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

oliguria: Producing much less urine than normal, which is often a sign the kidneys are under stress.

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

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

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

package insert: The detailed printed information about a medicine, written for health professionals, that comes with the product.

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.

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.

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.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

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

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

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.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

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.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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.

100 tablets68382-0856-01 7,666 Rx · $80,113

500 tablets68382-0856-05 2,770 Rx · $25,238

1000 tablets68382-0856-10 No Medicaid data

100 tablets this page68382-0856-77 No Medicaid data

Drug total (last 4 qtrs): 10,436 Rx · 471,666 units · $105,351 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Pharmaceuticals (USA) Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 100 tablets (68382-0856-01), 500 tablets (68382-0856-05), 1000 tablets (68382-0856-10). 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?

Zydus Pharmaceuticals (USA) Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

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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.

Related NDC lookups

🧪 All Triamterene And Hydrochlorothiazide NDCsSame ingredient 🏭 All Zydus labeler NDCsLabeler code 68382 📚 All Potassium-sparing Diuretic NDCsDrug class 📖 Read the Triamterene And Hydrochlorothiazide drug informationUses, warnings & side effects

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Spironolact/Hydrochlorothiazid 00025-1011-31 Amiloride/Hydrochlorothiazide 00378-0577-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

triamterene and hydrochlorothiazide 37.5 mg; 25 mg Tablet, 100-count — NDC 68382-856-77 (Billing 68382-0856-77)

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