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Hydrochlorothiazide 12.5 mg Capsule, 300-count — NDC 65862-0113-33 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrochlorothiazide 12.5 mg Capsule, 300-count — NDC 65862-113-33 (Billing 65862-0113-33)

by Aurobindo Pharma Limited · 300 CAPSULE in 1 BOTTLE

This is a package of 300 capsules of Hydrochlorothiazide 12.5 mg Capsule from Aurobindo Pharma Limited, marketed since Sep 2007 and currently FDA-listed.

NDC 65862-0113-33
🏷️ FDA NDC (as labeled) 65862-113-33 billing pads the product segment with a zero
This package
Contains300-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.0976/unit — full pricing hub ↓
Product page 65862-0113-01 Also comes in: 100 capsules 65862-113-01 500 capsules 65862-113-05 1000 capsules 65862-113-99 3000 capsules 65862-113-39
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) 65862-113-33
Product NDC 65862-113
11-digit billing NDC 65862011333
RxCUI 199903
UNII 0J48LPH2TH
Application # ANDA078164
SPL Set ID e31bd548-29ae-419a-831a-80ebb26e042f
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 2007-09-19
Route ORAL
Dosage form CAPSULE
Substance HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 37600040000110
GPI class hydroCHLOROthiazide
GCN Seq No 029832
GCN 34820
HICL code 003649
Ingredient (HICL) Hydrochlorothiazide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1F
Therapeutic class — specific (HIC3) Thiazide And Related Diuretics
AHFS code 24:36.20.00
AHFS class Thiazide Diuretics (24:36)
FDB label name HYDROCHLOROTHIAZIDE 12.5 MG CP
FDB brand name Hydrochlorothiazide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 029832
  • GCN: 34820
  • GPI-14 (Medi-Span): 37600040000110
  • HICL (First Databank): 003649
  • AHFS class code: 24:36.20.00
  • RxCUI (RxNorm): 199903
Why two NDCs? The FDA registers this code as 65862-113-33 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65862-0113-33. 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

Label name HYDROCHLOROTHIAZIDE 12.5 MG CP Ingredient Hydrochlorothiazide
📖 What it is MedlinePlus · NLM

Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works 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...

Read the full MedlinePlus article ↗
📗 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 $0.0976 $29.28 / 300 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65862-0113-01 65862-113-01 Main listing 100 CAPSULE in 1 BOTTLE 2007-09-19 — Active
65862-0113-05 65862-113-05 500 CAPSULE in 1 BOTTLE 2007-09-19 — Active
65862-0113-33 You're viewing this 300 CAPSULE in 1 BOTTLE 2007-09-19 — Active
65862-0113-99 65862-113-99 1000 CAPSULE in 1 BOTTLE 2007-09-19 — Active
65862-0113-39 65862-113-39 3000 CAPSULE in 1 BAG — — Active

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

Pack size FAQ

What quantity is in this package?
This is a 300-count package — 300 capsule in 1 bottle.
How does this package differ from NDC 65862-0113-01?
Both are Hydrochlorothiazide 12.5 mg Capsule — the drug itself is identical. This page's package is the 300-count one, while NDC 65862-0113-01 is the 100 capsules package.
What NDC number is used to bill for this package of Hydrochlorothiazide 12.5 mg Capsule?
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 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 mgthis 65862-0113-33 Aurobindo 300 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 mg 68788-8862-01 Preferred 100 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 —
hydrochlorothiazide 12.5 mg 68788-4192-01 Preferred 100 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

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 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 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 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA078164 (ANDA)
Labeler code65862
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio1,456 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Hydrochloro­thiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combina­tion diuretic products, hydrochloro­thiazide 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 rou­tine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unneces­sary hazard.

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

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

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

⏱️ Dosage and Administration 38 words ▾

DOSAGE AND ADMINISTRATION For Control of Hypertension: The adult initial dose of hydrochloro­thiazide 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 con­traindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also con­traindicated.

⚠️ 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 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: Cholestyramine and colestipol resins bind the hydrochlorothiazide and re­duce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroid, 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 greatly increase the 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. When hydrochloro­thiazide 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 sodi­um traversing the distal tubule and the volume of water excret­ed. A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydro­chlorothiazide and depletion of sodium, compensatory mecha­nisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen and chloride ions.

Hydrochlorothiazide also decreases the excretion of cal­cium and uric acid, may increase the excretion of iodide and may reduce glomerular fil­tration rate. Metabolic toxicities associated with excessive elec­trolyte changes caused by hydrochlorothiazide have been shown to be dose-related. Pharmacokinetics and Metabolism: Hydrochlorothiazide is well absorbed (65% to 75%) fol­lowing oral administration.

Absorption of hydrochlorothi­azide 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 follow­ing oral doses of 12.5 to 100 mg. Plasma concentra­tions are linearly related to the administered dose.

Concen­trations 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 approxi­mately 40% to 68%. The plas­ma 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 con­centrations of hydrochlorothi­azide are increased and the elimination half-life is pro­longed.

When hydrochloro­thiazide is adminis­tered with food, its bioavailabil­ity is reduced by 10%, the max­imum 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 thi­azides are thought to result from a reduction in blood vol­ume and cardiac output, sec­ondary to a natriuretic effect, although a direct vasodilatory mechanism has also been pro­posed. With chronic adminis­tration, plasma volume returns toward normal, but peripheral vascular resistance is de­creased.

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 dos­ing, peak effect is observed at about 4 hours, and activity per­sists for up to 24 hours.

Clinical Studies: In an 87 patient 4-week double-blind, placebo controlled, parallel group trial, patients who received hydrochloro­thiazide 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 com­paring 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 128 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 100 NDC 65862-113-01 Bottles of 300 NDC 65862-113-33 Bottles of 500 NDC 65862-113-05 Bottles of 1,000 NDC 65862-113-99 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: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2022

📋 Description 116 words ▾

DESCRIPTION Hydrochloro­thiazide 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.

Hydrochloro­thiazide 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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Electrolyte and Fluid Balance Status: In published studies, clinically significant hypokalemia has been consistently less common in patients who received 12.5 mg of hydro­chlorothiazide than in patients who received higher doses. Nevertheless, periodic determi­nation of serum electrolytes should be performed in patients who may be at risk for the development of hypo­kalemia. Patients should be observed for signs of fluid or electrolyte disturbances, i.e., hyponatremia, hypochloremic alkalosis, and hypokalemia and hypomagnesemia.

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. Hypokalemia may develop, especially with brisk diuresis when severe cirrhosis is pres­ent, during concomitant use of corticosteroid or adrenocorti­cotropic hormone (ACTH) or after prolonged therapy. Interference with adequate oral electrolyte intake will also con­tribute to hypokalemia.

Hypo­kalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of dig­italis. Hypokalemia may be avoided or treated by potas­sium supplementation or increased intake of potassium rich foods. Dilutional hyponatremia is life-threatening and may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when the hypo­natremia is life-threatening.

In actual salt depletion, appropri­ate replacement is the therapy of choice. Hyperuricemia: Hyperuricemia or acute gout may be precipi­tated in certain patients receiv­ing thiazide diuretics. Impaired Hepatic Function: Thiazides should be used with caution in patients with impaired hepatic function.

They can precipitate hepatic coma in patients with severe liver dis­ease. Parathyroid Disease: Calcium excretion is decreased by thi­azides, and pathologic changes in the parathyroid glands, with hypercalcemia and hypophos­phatemia, have been observed in a few patients on prolonged thiazide therapy. Information for Patients: Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

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: Cholestyramine and colestipol resins bind the hydrochlorothiazide and re­duce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroid, 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 greatly increase the 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. When hydrochloro­thiazide 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 obta… [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.

🧬 Pharmacokinetics 190 words ▾

Pharmacokinetics and Metabolism: Hydrochlorothiazide is well absorbed (65% to 75%) fol­lowing oral administration. Absorption of hydrochlorothi­azide 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 follow­ing oral doses of 12.5 to 100 mg.

Plasma concentra­tions are linearly related to the administered dose. Concen­trations 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 approxi­mately 40% to 68%.

The plas­ma 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 con­centrations of hydrochlorothi­azide are increased and the elimination half-life is pro­longed. When hydrochloro­thiazide is adminis­tered with food, its bioavailabil­ity is reduced by 10%, the max­imum plasma concentration is reduced by 20%, and the time to maximum concentration increases from 1.6 to 2.9 hours.

🧬 Pharmacodynamics 91 words ▾

Pharmacodynamics: Acute antihypertensive effects of thi­azides are thought to result from a reduction in blood vol­ume and cardiac output, sec­ondary to a natriuretic effect, although a direct vasodilatory mechanism has also been pro­posed. With chronic adminis­tration, plasma volume returns toward normal, but peripheral vascular resistance is de­creased. 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 dos­ing, peak effect is observed at about 4 hours, and activity per­sists for up to 24 hours.

🔬 Clinical Studies 66 words ▾

Clinical Studies: In an 87 patient 4-week double-blind, placebo controlled, parallel group trial, patients who received hydrochloro­thiazide 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 com­paring 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 209 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 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 1,300 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 32 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12.5 mg (100 Capsule Bottle) NDC 65862-113-01 Rx only Hydrochlorothiazide Capsules USP 12.5 mg AUROBINDO 100 Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12.5 mg (100 Capsule Bottle)

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 ✓ 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 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 Aurobindo Pharma Limited. 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 100 capsules (65862-0113-01), 500 capsules (65862-0113-05), 1000 capsules (65862-0113-99). 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?
Aurobindo Pharma Limited 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.
← 65862-0107-01 · Aurobindo 65862-0117-01 · Aurobindo →
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.