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Hydrochlorothiazide 25 mg Tablet, 20-count — NDC 68071-4963-1 (Billing 68071-4963-01)

by NuCare Pharmaceuticals,Inc. · 20 TABLET in 1 BOTTLE

This is a package of 20 tablets of Hydrochlorothiazide 25 mg Tablet from NuCare Pharmaceuticals,Inc., marketed since Jan 1973 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68071-4963-01
🏷️ FDA NDC (as labeled) 68071-4963-1 billing pads the package segment with a zero
This package
Contains20-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0822/unit — full pricing hub ↓
Main listing for product 68071-4963 · Also comes in: 90 tablets 68071-4963-9
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) 68071-4963-1
Product NDC 68071-4963
11-digit billing NDC 68071496301
RxCUI 310798
UNII 0J48LPH2TH
UPC 0368071496321
Application # ANDA083177
SPL Set ID 8d5a9196-5f1d-2d83-e053-2a95a90a6036
Established class (EPC) Thiazide Diuretic
Physiologic effect Increased Diuresis
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1973-01-12
Route ORAL
Dosage form TABLET
Substance HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 310798
Why two NDCs? The FDA registers this code as 68071-4963-1 — 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 → 68071-4963-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Thiazide Diuretic class.

Pharmacologic class Thiazide Diuretic
Drug family (ATC) Renin-inhibitors, Thiazides, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It lowers high blood pressure, which helps reduce the risk of strokes and heart attacks. Some products, such as Inzirqo and the tablets, are also used for swelling from conditions...
  • Take it by mouth exactly as prescribed, usually once a day. For swelling, your prescriber may have you take it only some days of the week. Food slightly lowers absorption, so ask m...
  • Dizziness, lightheadedness when standing, stomach upset, headache and weakness are the usual ones. Stand up slowly, and be careful with alcohol since it can worsen dizziness. Use s...
  • Call for eye pain or sudden vision changes, severe rash or blistering, trouble breathing, severe stomach pain, yellow skin or eyes, or unusual bruising or infections. Also call for...
📖 Read our full Hydrochlorothiazide guide →
8
Nutrient depletion considerations

Hydrochlorothiazide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrochlorothiazide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 $0.0822 $1.64 / 20 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 Marketing startMarketing endStatus
68071-4963-09 68071-4963-9 90 TABLET in 1 BOTTLE 2019-07-10 — Active
68071-4963-01 You're viewing this Main listing 20 TABLET in 1 BOTTLE 2019-07-10 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 20-count package — 20 tablet in 1 bottle.
How does this package differ from NDC 68071-4963-09?
Both are Hydrochlorothiazide 25 mg Tablet — the drug itself is identical. This page's package is the 20-count one, while NDC 68071-4963-09 is the 90 tablets package.
What NDC number is used to bill for this package of Hydrochlorothiazide 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrochlorothiazide 25 mg 00172-2083-60 Teva 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 16729-0183-01 Accord 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 23155-0008-01 Heritage 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 29300-0128-01 Unichem 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 60687-0593-01 American 100 tablets $0.012 — Availability likely —
Hydrochlorothiazide 25 mg 60687-0894-01 American 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 62135-0448-05 Chartwell 500 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 68645-0510-54 Legacy 30 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 69315-0131-01 Leading 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 69584-0361-10 Oxford 100 tablets $0.012 AB Availability likely —
Hydrochlorothiazide 25 mg 00615-8450-05 NCS 15 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 42708-0028-30 QPharma, 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 42708-0079-30 QPharma, 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 42708-0164-30 QPharma 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 43353-0719-15 Aphena 15 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 43547-0397-01 Solco 10 tablets — — FDA listed —
Hydrochlorothiazide 25 mg 50090-0140-00 A-S 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-0141-00 A-S 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-5057-00 A-S 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-5333-00 A-S 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-6014-00 A-S 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-6157-00 A-S 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-6158-00 A-S 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50090-6160-00 A-S 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 50228-0111-10 ScieGen 1000 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 51407-0331-01 Golden 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 51655-0088-52 Northwind 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 51655-0272-26 Northwind 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 51655-0515-26 Northwind 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 51655-0831-26 Northwind 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 55700-0006-30 Lake 30 tablets — AB Discontinued —
Hydrochlorothiazide 25 mg 60760-0315-30 St. 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 63187-0367-00 Proficient 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 63187-0440-30 Proficient 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 63629-1218-01 Bryant 100 tablets — — FDA listed —
Hydrochlorothiazide 25 mg 65862-0133-01 Aurobindo 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 66267-0106-30 NuCare 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 67296-2043-03 Redpharm 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 68071-2411-01 NuCare 20 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 68071-4819-01 NuCare 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 68071-4933-07 NuCare 20 tablets — AB FDA listed —
Hydrochlorothiazide 25 mgthis 68071-4963-01 NuCare 20 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 68071-5211-02 NuCare 120 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 68788-8517-00 Preferred 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 70518-3633-00 REMEDYREPACK 30 tablets — AB Discontinued —
Hydrochlorothiazide 25 mg 70518-3749-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 70518-4113-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 70518-4359-00 REMEDYREPACK 15 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71205-0419-30 Proficient 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71205-0793-30 Proficient 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71335-0269-00 Bryant 120 tablets — AB Discontinued —
Hydrochlorothiazide 25 mg 71335-0652-00 Bryant 8 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71335-1481-00 Bryant 120 tablets — — FDA listed —
Hydrochlorothiazide 25 mg 71610-0488-15 Aphena 15 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 72789-0296-30 PD-Rx 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 72789-0381-90 PD-Rx 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 72789-0512-30 PD-Rx 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 76282-0154-01 Exelan 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 82804-0972-00 Proficient 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 87441-0038-01 Unit 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 67296-2280-09 Redpharm 90 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

🏛️
1973
On the market since
Jan 1973
📍
2026
Currently FDA-listed
53 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.

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
FDA applicationANDA083177 (ANDA)
Labeler code68071
First marketedJan 1973
Product typeHuman Prescription Drug
Portfolio1,015 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 Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

Use in Pregnancy Routine use of diuretics during normal pregnancy 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 toxemia. Edema during pregnancy may arise from pathologic 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 (see PRECAUTIONS, Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary.

During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief.

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

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response. Adults For Edema The usual adult dosage is 25 mg to 100 mg daily as a single or divided dose.

Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur. For Control of Hypertension The usual initial dose in adults is 25 mg daily given as a single dose.

The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS ). Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

Infants and Children For Diuresis and for Control of Hypertension The usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required (see PRECAUTIONS, Pediatric Use ).

⛔ Contraindications 11 words ▾

CONTRAINDICATIONS Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.

⚠️ Warnings 209 words ▾

WARNINGS Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides 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. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions ). 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 149 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole Weakness. Cardiovascular Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Digestive Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal Muscle spasm. Nervous System/Psychiatric Vertigo, paresthesias, dizziness, headache, restlessness.

Renal Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ). Skin Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses Transient blurred vision, xanthopsia.

Urogenital Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

🔄 Drug Interactions 217 words ▾

Drug Interactions When given concurrently the following drugs may interact with thiazide diuretics. Alcohol, Barbiturates, or Narcotics Potentiation of orthostatic hypotension may occur. Antidiabetic Drugs (Oral Agents And Insulin) Dosage adjustment of the antidiabetic drug may be required.

Other Antihypertensive Drugs Additive effect or potentiation. Cholestyramine and Colestipol Resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.

Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia. Pressor Amines (e.g., Norepinephrine) Possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine) Possible increased responsiveness to the muscle relaxant.

Lithium Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide.

Non-Steroidal Anti-Inflammatory Drugs In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

🔄 Drug / Laboratory Test Interactions 18 words ▾

Drug/Laboratory Test Interactions Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General ).

🤰 Pregnancy 108 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided 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 cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

🧒 Pediatric Use 48 words ▾

Pediatric Use There are no well controlled clinical trials in pediatric patients. Information on dosing in this age group is supported by evidence from empiric use in pediatric patients and published literature regarding the treatment of hypertension in such patients (see DOSAGE AND ADMINISTRATION, Infants and Children ).

🆘 Overdosage 104 words ▾

OVERDOSAGE The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed.

Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment.

The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

🧬 Clinical Pharmacology 151 words ▾

CLINICAL PHARMACOLOGY The mechanism of the antihypertensive effect of thiazides is unknown. Hydrochlorothiazide does not usually affect normal blood pressure. Hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption.

At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy. Hydrochlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.

After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. Pharmacokinetics and Metabolism Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours.

At least 61% of the oral dose is eliminated unchanged within 24 hours. Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.

📦 How Supplied / Storage and Handling 94 words ▾

HOW SUPPLIED Hydrochlorothiazide Tablets USP, 25 mg are available as round, light orange, flat face, beveled edge tablets, bisected on one side, debossed 2083 and TEVA on the other side, containing 25 mg hydrochlorothiazide USP. NDC 68071-4963-1 BOTTLES OF 20 NDC 68071-4963-9 BOTTLES OF 90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev.

H 5/2016

📋 Description 124 words ▾

DESCRIPTION Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: C 7 H 8 ClN 3 O 4 S 2 M.W.

297.74 Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No.

6 Lake, lactose monohydrate and magnesium stearate. HCTZ structural formula

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability).

Hypokalemia may be avoided or treated by use of potassium sparing diuretics or potassium supplements such as foods with a high potassium content. Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis. Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening.

In actual salt depletion, appropriate replacement is the therapy of choice. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazides. In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.

Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy. The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

If progressive renal impairment becomes evident, consider withholding or discontinuing diuretic therapy. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Thiazides may decrease urinary calcium excretion.

Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Laboratory Tests Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals. Drug Interactions When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, Barbiturates, or Narcotics Potentiation of orthostatic hypotension may occur. Antidiabetic Drugs (Oral Agents And Insulin) Dosage adjustment of the antidiabetic drug may be required. Other Antihypertensive Drugs Additive effect or potentiation.

Cholestyramine and Colestipol Resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia.

Pressor Amines (e.g., Norepinephrine) Possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine) Possible increased responsiveness to the muscle relaxant. Lithium Generally should not be given with diuretics.

Diuretic agent… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 43 words ▾

Nursing Mothers Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue hydrochlorothiazide, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 212 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Two year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in 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 only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration. 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, respectively, prior to conception and throughout gestation.

📄 Package Label / Principal Display Panel 4 words ▾

Package/Label Display Panel pdp

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

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

Medicare Part D (outpatient prescription) spending for Hydrochlorothiazide — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydrochlorothiazide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$20.24M
Claims incl. refills
4.4M
Beneficiaries
3.6M
Spend / beneficiary
$5.65
Spend / claim
$4.63
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 — Not published for this NDC No photo available yet for this listing.
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 NuCare Pharmaceuticals,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 1 other package presentation of this same product, including 90 tablets (68071-4963-09). 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?
NuCare Pharmaceuticals,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.
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.
← 68071-4962-09 · NuCare 68071-4964-03 · NuCare →
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.