HomeNDC LookupIngredientsHydrochlorothiazide › 68788-8862-03
Hydrochlorothiazide 12.5 mg Capsule, 30-count — NDC 68788-8862-03 package photo

Hydrochlorothiazide 12.5 mg Capsule, 30-count

by Preferred Pharmaceuticals Inc. · 30 CAPSULE in 1 BOTTLE (68788-8862-3)
NDC 68788-8862-03
🏷️ FDA NDC (as labeled) 68788-8862-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.0976/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68788-8862-3
Product NDC 68788-8862
11-digit billing NDC 68788886203
NCPDP billing unit EA — each (per item)
RxCUI 199903
UNII 0J48LPH2TH
Application # ANDA078164
SPL Set ID 82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b0
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 2025-04-29
Route ORAL
Dosage form CAPSULE
Substance HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68788-8862-3 — 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 → 68788-8862-03. 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.

🏭 Manufacturer & labeler

LabelerPreferred Pharmaceuticals Inc.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA078164 (ANDA)
Labeler code68788
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio825 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's a water pill — it makes your kidneys flush out extra salt and water, which reduces the amount of fluid your body is holding. That directly lowers your blood pressure and reduc...
  • What exactly is hydrochlorothiazide supposed to do for me?
  • You can take it either way, but be consistent — take it the same way each time. Food does reduce absorption slightly, but what matters most is that you take it regularly as prescri...
  • Should I take it with food or on an empty stomach?
📖 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.

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.

💊 What it looks like

Color Blue
ShapeCapsule
ImprintD;26
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

12 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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price 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 $0.0976 $2.93 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrochlorothiazide 12.5 mg 00591-0347-01 Actavis 100 capsules $0.028 AB Availability likely
hydrochlorothiazide 12.5 mg 29300-0130-01 Unichem 100 capsules $0.028 AB Availability likely
Hydrochlorothiazide 12.5 mg 50228-0146-01 ScieGen 100 capsules $0.028 AB Availability likely
Hydrochlorothiazide 12.5 mg 50268-0404-15 AvPAK 50 capsules $0.028 AB Availability likely
Hydrochlorothiazide 12.5 mg 57237-0002-01 Rising 100 capsules $0.028 AB Availability likely
hydrochlorothiazide 12.5 mg 60687-0683-01 American 100 capsules $0.028 AB Availability likely
Hydrochlorothiazide 12.5 mg 69367-0219-01 Westminster 100 capsules $0.028 AB Availability likely
Hydrochlorothiazide 12.5 mg 00615-8344-05 NCS 15 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 35356-0807-30 Quality 30 capsules AB Discontinued
Hydrochlorothiazide 12.5 mg 42708-0027-30 QPharma, 30 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 42708-0086-30 QPharma 30 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 46708-0438-10 Alembic 100 capsules FDA listed
hydrochlorothiazide 12.5 mg 50090-0724-00 A-S 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 50090-6987-00 A-S 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 50090-6988-00 A-S 90 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 51655-0522-26 Northwind 90 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 51655-0616-26 Northwind 90 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 62332-0070-10 Alembic 100 capsules FDA listed
Hydrochlorothiazide 12.5 mg 63187-0548-07 Proficient 7 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 63629-8498-01 Bryant 500 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 65862-0113-01 Aurobindo 100 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 67544-0739-60 Aphena 90 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 68788-7683-01 Preferred 100 capsules AB FDA listed
Hydrochlorothiazide 12.5 mgthis 68788-8862-03 Preferred 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 70518-2550-00 REMEDYREPACK 30 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 71205-0161-07 Proficient 7 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 71205-0589-30 Proficient 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 71205-0980-00 Proficient 100 capsules AB FDA listed
hydrochlorothiazide 12.5 mg 71335-0067-01 Bryant 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 71335-0770-01 Bryant 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 71335-1713-01 Bryant 30 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 71610-0500-60 Aphena 90 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 71610-0697-60 Aphena 90 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 72162-1528-05 Bryant 500 capsules AB FDA listed
Hydrochlorothiazide 12.5 mg 72789-0176-30 PD-Rx 30 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for HYDROCHLOROTHIAZIDE — the ingredient across all brands.

Top reported reactions

Fatigue13,772
Nausea13,724
Diarrhoea11,763
Dizziness11,243
Headache10,766
Dyspnoea10,494
Pain10,309

Age at onset

Neonate132
Infant58
Child56
Adolescent53
Adult11,981
Elderly14,690

Reporter sex

209,395 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization71,774
Death14,539
Life-threatening8,600
Disabling5,463
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,176 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68788-8862-01 100 CAPSULE in 1 BOTTLE (68788-8862-1) 2025-04-29 Active
68788-8862-03 You're viewing this 30 CAPSULE in 1 BOTTLE (68788-8862-3) 2025-04-29 Active
68788-8862-06 60 CAPSULE in 1 BOTTLE (68788-8862-6) 2025-04-29 Active
68788-8862-07 7 CAPSULE in 1 BOTTLE (68788-8862-7) 2025-04-29 Active
68788-8862-09 90 CAPSULE in 1 BOTTLE (68788-8862-9) 2025-04-29 Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68788-8862-03?
NDC 68788-8862-03 is a 30-count package — 30 capsule in 1 bottle.
What is the difference between NDC 68788-8862-03 and NDC 68788-8862-07?
Both are Hydrochlorothiazide 12.5 mg Capsule — the drug itself is identical. NDC 68788-8862-03 is the 30-count package, while NDC 68788-8862-07 is the 7 capsules package.
What NDC number is used to bill for this package of Hydrochlorothiazide 12.5 mg Capsule?
Bill NDC 68788-8862-03 — the 11-digit billing format is 68788886203. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68788-8862-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68788-8862-03, written without dashes as 68788886203. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68788-8862-03, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals Inc.; the middle segment (8862) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Preferred 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 4 other package presentations of this same product, including 7 capsules (68788-8862-07), 60 capsules (68788-8862-06), 90 capsules (68788-8862-09). 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?
Preferred 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE Hydrochloro‑thiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combina‑tion diuretic products, hydrochloro‑thiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The rou‑tine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unneces‑sary hazard.

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

Dependent edema in pregnan‑cy 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 unneces‑sary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular dis‑ease), but which is associated with edema, including general‑ized edema in the majority of pregnant women. If this edema produces discomfort, in‑creased 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 38 words

DOSAGE AND ADMINISTRATION For Control of Hypertension: The adult initial dose of hydrochloro‑thiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.

Contraindications 21 words

CONTRAINDICATIONS Hydrochlorothiazide capsules are con‑traindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also con‑traindicated.

⚠️ Warnings 141 words

WARNINGS 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.

Diabetes and Hypoglycemia: Latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose. Renal Disease: Cumulative effects of the thiazides may develop in patients with impaired renal function. In such patients, thiazides may precipitate azotemia.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the 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, paresthesia, 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. Postmarketing Experience: The following adverse reaction has been identified during post-approval use of hydrochlorothiazide. Because the reaction is reported voluntarily from a population of uncertain size, it is not possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

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 201 words

Drug Interactions: When given concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics: potentiation of ortho‑static 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: Cholestyramine and colestipol resins bind the hydrochlorothiazide and re‑duce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroid, ACTH: intensi‑fied 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 clear‑ance of lithium and greatly increase the risk of lithium tox‑icity.

Refer to the package insert for lithium preparations before use of such preparations with hydrochloro‑thiazide. 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. When hydrochloro‑thiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patients 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 105 words

Pregnancy: Teratogenic Effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3,000 and 1,000 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 12 words

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

🧓 Geriatric Use 49 words

Geriatric Use: A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e., >65 years) with hydrochlorothiazide. Starting treatment with the lowest available dose of hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.

🆘 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 gm/kg in the mouse and rat.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Hydrochlorothiazide blocks the reabsorption of sodium and chloride ions, and it thereby increases the quantity of sodi‑um traversing the distal tubule and the volume of water excret‑ed. A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydro‑chlorothiazide and depletion of sodium, compensatory mecha‑nisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen and chloride ions.

Hydrochlorothiazide also decreases the excretion of cal‑cium and uric acid, may increase the excretion of iodide and may reduce glomerular fil‑tration rate. Metabolic toxicities associated with excessive elec‑trolyte changes caused by hydrochlorothiazide have been shown to be dose-related. Pharmacokinetics and Metabolism: Hydrochlorothiazide is well absorbed (65% to 75%) fol‑lowing oral administration.

Absorption of hydrochlorothi‑azide is reduced in patients with congestive heart failure. Peak plasma concentrations are observed within 1 to 5 hours of dosing and range from 70 to 490 ng/mL follow‑ing oral doses of 12.5 to 100 mg. Plasma concentra‑tions are linearly related to the administered dose.

Concen‑trations of hydrochlorothiazide are 1.6 to 1.8 times higher in whole blood than in plasma. Binding to serum proteins has been reported to be approxi‑mately 40% to 68%. The plas‑ma elimination half-life has been reported to be 6 to 15 hours.

Hydrochlorothiazide is eliminated primarily by renal pathways. Following oral doses of 12.5 to 100 mg, 55% to 77% of the administered dose appears in urine and greater than 95% of the absorbed dose is excreted in urine as unchanged drug. In patients with renal disease, plasma con‑centrations of hydrochlorothi‑azide are increased and the elimination half-life is pro‑longed.

When hydrochloro‑thiazide is adminis‑tered with food, its bioavailabil‑ity is reduced by 10%, the max‑imum plasma concentration is reduced by 20%, and the time to maximum concentration increases from 1.6 to 2.9 hours. Pharmacodynamics: Acute antihypertensive effects of thi‑azides are thought to result from a reduction in blood vol‑ume and cardiac output, sec‑ondary to a natriuretic effect, although a direct vasodilatory mechanism has also been pro‑posed. With chronic adminis‑tration, plasma volume returns toward normal, but peripheral vascular resistance is de‑creased.

The exact mechanism of the antihypertensive effect of hydrochlorothiazide is not known. Thiazides do not affect normal blood pressure. Onset of action occurs within 2 hours of dos‑ing, peak effect is observed at about 4 hours, and activity per‑sists for up to 24 hours.

Clinical Studies: In an 87 patient 4-week double-blind, placebo controlled, parallel group trial, patients who received hydrochloro‑thiazide had reductions in seated systolic and diastolic blood pressure that were significantly greater than those seen in patients who received placebo. In published placebo-controlled trials com‑paring 12.5 mg of hydrochlorothiazide to 25 mg, the 12.5 mg dose preserved most of the placebo-corrected blood pressure reduction seen with 25 mg.

📦 How Supplied / Storage and Handling 132 words

HOW SUPPLIED Hydrochlorothiazide Capsules USP 12.5 mg are blue/blue size ‘4’ hard gelatin capsules, imprinted with ‘D’ on blue cap and ‘26’ on blue body with black edible ink, filled with white to off-white powder. Bottles of 7 NDC 68788-8862-7 Bottles of 30 NDC 68788-8862-3 Bottles of 60 NDC 68788-8862-6 Bottles of 90 NDC 68788-8862-9 Bottles of 100 NDC 68788-8862-1 Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.

Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Code: TS/DRUGS/19/1993 Revised: 09/2024 Repackaged By: Preferred Pharmaceuticals Inc.

📋 Description 116 words

DESCRIPTION Hydrochloro‑thiazide is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 ; its molecular weight is 297.74; and its structural formula is: It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Hydrochloro‑thiazide is supplied as 12.5 mg capsules for oral use. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, and magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, sodium lauryl sulphate, FD&C Blue #1, D&C Red #28, D&C Yellow #10, black iron oxide and shellac.

Chemical Structure

💬 Information for Patients 22 words

Information for Patients: Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.