Home › NDC Lookup › Ingredients › Hydrochlorothiazide › 70518-3633-00
⚪image loading
(from DailyMed)

HYDROCHLOROTHIAZIDE 25 mg Tablet, 30-count

by REMEDYREPACK INC. · 30 TABLET in 1 BLISTER PACK (70518-3633-0)
NDC 70518-3633-00
🏷️ FDA NDC (as labeled) 70518-3633-0 billing pads the package segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also comes in: 15 tablets 70518-3633-03 90 tablets 70518-3633-01
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70518-3633-0
Product NDC 70518-3633
11-digit billing NDC 70518363300
RxCUI 310798
UNII 0J48LPH2TH
Application # ANDA085182
SPL Set ID db1213f0-a981-4d30-86b3-372e4dadc734
Established class (EPC) Thiazide Diuretic
Physiologic effect Increased Diuresis
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2023-02-06
Marketing end 2026-06-30
Route ORAL
Dosage form TABLET
Substance HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-3633-0 — 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 → 70518-3633-00. 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

LabelerREMEDYREPACK INC.
Application holderHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC
FDA applicationANDA085182 (ANDA)
Labeler code70518
First marketedFeb 2023
Product typeHuman Prescription Drug
Portfolio1,502 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.

🧪 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

💲 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 tablets 90 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.

🔁 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 mg 68071-4963-09 NuCare 90 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 mgthis 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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.

📊 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
70518-3633-00 You're viewing this 30 TABLET in 1 BLISTER PACK (70518-3633-0) 2023-02-06 Discontinued by firm
70518-3633-01 90 TABLET in 1 BOTTLE, PLASTIC (70518-3633-1) 2023-07-19 Discontinued by firm
70518-3633-03 15 TABLET in 1 BOTTLE, PLASTIC (70518-3633-3) 2024-09-26 Discontinued by firm

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

Pack size FAQ

What quantity is in NDC 70518-3633-00?
NDC 70518-3633-00 is a 30-count package — 30 tablet in 1 blister pack.
What is the difference between NDC 70518-3633-00 and NDC 70518-3633-03?
Both are HYDROCHLOROTHIAZIDE 25 mg Tablet — the drug itself is identical. NDC 70518-3633-00 is the 30-count package, while NDC 70518-3633-03 is the 15 tablets package.
What NDC number is used to bill for this package of HYDROCHLOROTHIAZIDE 25 mg Tablet?
Bill NDC 70518-3633-00 — the 11-digit billing format is 70518363300. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 70518-3633-0, 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: 70518-3633-00, written without dashes as 70518363300. 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 70518-3633-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (3633) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 15 tablets (70518-3633-03), 90 tablets (70518-3633-01). 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?
REMEDYREPACK 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 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 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 three to five 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 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 imparied 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 ~1 min read ▾

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. Musculosketetal: 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. Postmarketing Experience Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.

In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year. Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTION, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

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 percent, 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 diluretics. 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.

🤰 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 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 comma 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 152 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 percent 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 131 words ▾

HOW SUPPLIED Hydrochlorothiazide Tablets USP, 25 mg are peach colored, round, debossed on one side with "H" above and "2" below the bisect and plain on the other side. Hydrochlorothiazide Tablets USP, 25 mg are supplied as follows: NDC: 70518-3633-00 NDC: 70518-3633-01 NDC: 70518-3633-02 NDC: 70518-3633-03 NDC: 70518-3633-04 NDC: 70518-3633-05 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 15 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 15 in 1 BOTTLE PLASTIC Dispense in a tight, light-resistant container.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr.

Suite #4 Indiana, PA 1-724-465-8762

📋 Description 133 words ▾

DESCRIPTION Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Its molecular formula is C 7 H 8 CIN 3 O 4 S 2 and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 297.74 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 12.5 mg, 25 mg or 50 mg of hydrochlorothiazide respectively. In addition, each tablet contains following inactive ingredients: anhydrous lactose, D&C Yellow No.10 aluminum lake, FD&C Red No.

40 aluminum lake, magnesium stearate, pregelatinized starch and sodium starch glycolate. Image

💬 Information for Patients 37 words ▾

Information for Patients Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70518-3630-00 · REMEDYREPACK 70518-3636-00 · REMEDYREPACK →
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.