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Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet, 6,500-count — NDC 60505-2656-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet, 6,500-count — NDC 60505-2656-7 (Billing 60505-2656-07)

by Apotex Corp. · 6500 TABLET in 1 BOTTLE

This is a package of 6,500 tablets of Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet from Apotex Corp., marketed since Sep 2009 and currently FDA-listed.

NDC 60505-2656-07
🏷️ FDA NDC (as labeled) 60505-2656-7 billing pads the package segment with a zero
This package
Contains6,500-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1535/unit — full pricing hub ↓
Product page 60505-2656-05 Also comes in: 100 tablets 60505-2656-1 500 tablets 60505-2656-5
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60505-2656-7
Product NDC 60505-2656
11-digit billing NDC 60505265607
RxCUI 310812, 310818
UNII 0J48LPH2TH, WS821Z52LQ
UPC 0360505265619, 0360505265718
Application # ANDA071251
SPL Set ID bd6c3495-ec70-908b-482a-a979506659e9
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 2009-09-21
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 60505-2656-7 — a 5-4-1 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 package segment → 60505-2656-07. 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.

Clinical

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

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.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1535 $997.75 / 6500 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
60505-2656-01 60505-2656-1 100 TABLET in 1 BOTTLE $0.0969 / ea $9.69 2009-09-21 — Active
60505-2656-05 60505-2656-5 Main listing 500 TABLET in 1 BOTTLE $0.0969 / ea $48.47 2009-09-21 — Active
60505-2656-07 You're viewing this 6500 TABLET in 1 BOTTLE — — 2009-09-21 — Active

You're viewing the largest of 3 pack sizes for this product.

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

Pack size FAQ

What quantity is in this package?
This is a 6,500-count package — 6500 tablet in 1 bottle.
How does this package differ from NDC 60505-2656-01?
Both are Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Tablet — the drug itself is identical. This page's package is the 6,500-count one, while NDC 60505-2656-01 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68001-0387-00 BluePoint 100 tablets $0.091 AB Discontinued —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 00591-0424-01 Actavis 100 tablets $0.097 — 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 68382-0856-01 Zydus 100 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 mgthis 60505-2656-07 Apotex 6500 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-1834-01 NuCare 100 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68071-2371-09 NuCare 90 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 68788-7526-01 Preferred 100 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 70518-1662-00 REMEDYREPACK 30 tablets — AB FDA listed —
triamterene and hydrochlorothiazide 37.5 mg/1; 25 mg 70771-1361-00 Zydus 1000 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-0356-01 Bryant 30 tablets — AB Discontinued —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-0968-01 Bryant 30 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-2631-01 Bryant 30 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71335-2806-01 Bryant 100 tablets — AB FDA listed —
triamterene and hydrochlorothiazide 37.5 mg/1; 25 mg 71610-0602-60 Aphena 90 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71610-0605-60 Aphena 90 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 71610-0684-60 Aphena 90 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 mg 72789-0183-30 PD-Rx 30 tablets — AB FDA listed —
Triamterene and Hydrochlorothiazide 37.5 mg/1; 25 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.

Availability & generic status

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 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.

What it looks like

Color Green / Yellow
ShapeOval
Imprint75;50;APO
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

6 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.

Manufacturer & labeler

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA071251 (ANDA)
Labeler code60505
First marketedSep 2009
Product typeHuman Prescription Drug
Portfolio306 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 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 tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).

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

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

Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief.

In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Note: 37.5 mg/25 mg = 37.5 mg triamterene and 25 mg hydrochlorothiazide 75 mg/50 mg = 75 mg triamterene and 50 mg hydrochlorothiazide The usual dose of Triamterene and Hydrochlorothiazide 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 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 tablet daily or more than two 37.5 mg/25 mg tablets daily.

Clinical experience with the administration of two 37.5 mg/25 mg 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 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg triamterene/25 mg hydrochlorothiazide directly.

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

⛔ Contraindications 128 words ▾

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

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

⚠️ Warnings ~2 min read ▾

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

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

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

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

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

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

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

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

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

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

🤒 Adverse Reactions ~1 min read ▾

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

🔄 Drug / Laboratory Test Interactions 21 words ▾

Drug/Laboratory Test Interactions Triamterene and quinidine have similar fluorescence spectra; thus, triamterene and hydrochlorothiazide may interfere with the measurement of quinidine.

🤰 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. 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. 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 benefits be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

🧒 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 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 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 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 largest increases in serum potassium, BUN and creatinine in this study w… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 197 words ▾

HOW SUPPLIED Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/ 25 mg are available for oral administration as green, oval biconvex tablets, scored and engraved “37.5” bisect “25” on one side, “APO” on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-2656-1) Bottles of 500 (NDC 60505-2656-5) Bottles of 6,500 (NDC 60505-2656-7) Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval biconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side.

They are supplied as follows: Bottles of 100 (NDC 60505-2657-1) Bottles of 500 (NDC 60505-2657-5) Bottles of 7,000 (NDC 60505-2657-7) Dispense with a child-resistant closure in a tight, light-resistant container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

APOTEX INC. TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP 37.5 mg/25 mg and 75 mg/50 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Manufactured by Piramal Pharma Limited, Plot No: 67-70 Sector-2 Pithampur 454775 Dist. Dhar, Madhya Pradesh, INDIA Mfg Lic. No.: 25/10/92 Revised September 2020 Rev.

3

📋 Description 192 words ▾

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

Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine.

Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids.

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

Its molecular weight is 297.73. The following is the structural formula:

⚠️ 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~3 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies with triamterene and hydrochlorothiazide tablets, the triamterene/hydrochlorothiazide combination, have not been conducted. Triamterene In studies conducted under the auspices of the National Toxicology Program, groups of rats were fed diets containing 0, 150, 300 or 600 ppm triamterene, and groups of mice were fed diets containing 0, 100, 200 or 400 ppm triamterene. Male and female rats exposed to the highest tested concentration received triamterene at about 25 and 30 mg/kg/day, respectively.

Male and female mice exposed to the highest tested concentration received triamterene at about 45 and 60 mg/kg/day, respectively. There was an increased incidence of hepatocellular neoplasia (primarily adenomas) in male and female mice at the highest dosage level. These doses represent 7.5 times and 10 times the MRHD of 300 mg/kg (or 6 mg/kg/day based on a 50 kg patient) for male and female mice, respectively when based on body-weight and 0.7 times and 0.9 times the MRHD when based on body-surface area.

Although hepatocellular neoplasia (exclusively adenomas) in the rat study was limited to triamterene-exposed males, incidence was not dose-dependent and there was no statistically significant difference from control incidence at any dose level. Hydrochlorothiazide Two-year feeding studies in mice and rats, conducted under the auspices of the National Toxicology Program (NTP), treated mice and rats with doses of hydrochlorothiazide up to 600 and 100 mg/kg/day, respectively. On a body-weight basis, these doses are 600 times (in mice) and 100 times (in rats) the Maximum Recommended Human Dose (MRHD) for the hydrochlorothiazide component of triamterene and hydrochlorothiazide tablets, (50 mg/day or 1 mg/kg/day based on a 50 kg patient).

On the basis of body-surface area, these doses are 56 times (in mice) and 21 times (in rats) the MRHD. These studies uncovered no evidence of carcinogenic potential of hydrochlorothiazide in rats or female mice, but there was equivocal evidence of hepatocarcinogenicity in male mice. Mutagenesis Studies of the mutagenic potential of triamterene and hydrochlorothiazide tablets, the triamterene/hydrochlorothiazide combination, have not been performed.

Triamterene Triamterene was not mutagenic in bacteria ( S. typhimurium strains TA 98, TA 100, TA 1535 or TA 1537) with or without metabolic activation. It did not induce chromosomal aberrations in Chinese hamster ovary (CHO) cells in vitro with or without metabolic activation, but it did induce sister chromatid exchanges in CHO cells in vitro with and without metabolic activation. Hydrochlorothiazide Hydrochlorothiazide was not genotoxic in in vitro assays using strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of Salmonella typhimurium (the Ames test), in the Chinese hamster ovary (CHO) test for chromosomal aberrations, or in in vivo assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.

Positive test results were obtained in the in vitro CHO sister chromatid exchange (clastogenicity) test, and in the mouse lymphoma cell (mutagenicity) assays, using concentrations of hydrochlorothiazide of 43 to 1300 mcg/mL. Positive test results were also obtained in the Aspergillus nidulans nondisjunction assay using an unspecified concentration of hydrochlorothiazide. Impairment of Fertility Studies of the effects of triamterene and hydrochlorothiazide tablets, the triamterene/hydrochlorothiazide combination, or of triamterene alone on animal reproductive function have not been conducted.

Hydrochlorothiazide Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation. Corresponding multiples of the MRHD are 100 (mice)… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 175 words ▾

PRINCIPAL DISPLAY PANEL-37.5 mg/ 25 mg Representative sample of labeling (see HOW SUPPLIED section for complete listing): APOTEX CORP. NDC 60505-2656-1 Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/ 25 mg Rx 100 bottle count

PRINCIPAL DISPLAY PANEL-75 mg/50 mg Representative sample of labeling (see HOW SUPPLIED section for complete listing): APOTEX CORP. NDC 60505-2657-1 Triamterene and Hydrochlorothiazide Tablets, USP 75 mg/50 mg Rx 100 bottle count

PRINCIPAL DISPLAY PANEL - 37.5 mg/25 mg - Piramal Representative sample of labeling (see HOW SUPPLIED section for complete listing): APOTEX CORP. NDC 60505-2656-1 Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/ 25 mg Rx 100 bottle count Piramal Pharma Limited, Plot No: 67-70 Sector-2 Pithampur 454775 Dist. Dhar, Madhya Pradesh, INDIA Mfg Lic. No.: 25/10/92

PRINCIPAL DISPLAY PANEL - 75 mg/50 mg - Piramal Representative sample of labeling (see HOW SUPPLIED section for complete listing): APOTEX CORP. NDC 60505-2657-1 Triamterene and Hydrochlorothiazide Tablets, USP 75 mg/50 mg Rx 100 bottle count Piramal Pharma Limited, Plot No: 67-70 Sector-2 Pithampur 454775 Dist. Dhar, Madhya Pradesh, INDIA Mfg Lic. No.: 25/10/92

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.
500 tablets60505-2656-05 23,261 Rx · $199,843
100 tablets60505-2656-01 17,122 Rx · $162,847
6500 tablets this page60505-2656-07 No Medicaid data
Drug total (last 4 qtrs): 40,383 Rx · 2,120,418 units · $362,689 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

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NDC identity (package / product / labeler codes) ✓ Available
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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.
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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 Apotex Corp.. 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 2 other package presentations of this same product, including 100 tablets (60505-2656-01), 500 tablets (60505-2656-05). 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?
Apotex Corp. 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.
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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.
← 60505-2655-01 · Apotex 60505-2657-01 · Apotex →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.