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Hydrochlorothiazide 25 mg Tablet, 50-count — NDC 43547-0397-05 package photo

Hydrochlorothiazide 25 mg Tablet, 50-count

by Solco Healthcare U.S., LLC · 50 TABLET in 1 BOTTLE, PLASTIC (43547-397-05)
NDC 43547-0397-05
🏷️ FDA NDC (as labeled) 43547-397-05 billing pads the product segment with a zero
This package
Contains50-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.0822/unit — full pricing hub ↓
Also comes in: 10 tablets 43547-0397-01 30 tablets 43547-0397-03 100 tablets 43547-0397-10 500 tablets 43547-0397-50 1000 tablets 43547-0397-11 5000 tablets 43547-0397-15
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 43547-397-05
Product NDC 43547-397
11-digit billing NDC 43547039705
RxCUI 197770, 310798
UNII 0J48LPH2TH
UPC 0343547397036
Application # ANDA040412
SPL Set ID 60c97ab9-b25e-4ea5-a159-792292178c65
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 2002-03-29
Route ORAL
Dosage form TABLET
Substance HYDROCHLOROTHIAZIDE
GPI-14 37600040000305
GPI class hydroCHLOROthiazide
GCN Seq No 008182
GCN 34824
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 25 MG TAB
FDB brand name Hydrochlorothiazide
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 43547-397-05 — 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 → 43547-0397-05. 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

LabelerSolco Healthcare U.S., LLC
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA040412 (ANDA)
Labeler code43547
First marketedMar 2002
Product typeHuman Prescription Drug
Portfolio56 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

Label name HYDROCHLOROTHIAZIDE 25 MG TAB Ingredient Hydrochlorothiazide
📗 Our plain-language guide HelloPharmacist
  • It's a water pill — a diuretic — that helps your kidneys flush out extra salt and water. This lowers your blood pressure and reduces swelling (edema) caused by conditions like hear...
  • What exactly is hydrochlorothiazide supposed to do for me?
  • Most people take it once daily in the morning — that way the extra trips to the bathroom happen during the day, not overnight. Taking it with food slightly reduces how much your bo...
  • When should I take it, and does it matter if I take it with food?
📖 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.

💊 What it looks like

Color Orange
ShapeRound
Imprint3572;V
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 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.

5 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.

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0822 $4.11 / 50 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 mgthis 43547-0397-05 Solco 50 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 mg 70518-3633-00 REMEDYREPACK 30 tablets — AB Discontinued —
Hydrochlorothiazide 25 mg 70518-3749-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 70518-4113-00 REMEDYREPACK 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 70518-4359-00 REMEDYREPACK 15 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71205-0419-30 Proficient 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71205-0793-30 Proficient 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71335-0269-00 Bryant 120 tablets — AB Discontinued —
Hydrochlorothiazide 25 mg 71335-0652-00 Bryant 8 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 71335-1481-00 Bryant 120 tablets — — FDA listed —
Hydrochlorothiazide 25 mg 71610-0488-15 Aphena 15 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 72789-0296-30 PD-Rx 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 72789-0381-90 PD-Rx 90 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 72789-0512-30 PD-Rx 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 76282-0154-01 Exelan 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 82804-0972-00 Proficient 100 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 87441-0038-01 Unit 30 tablets — AB FDA listed —
Hydrochlorothiazide 25 mg 67296-2280-09 Redpharm 90 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2002
On the market since
Mar 2002
📍
2026
Currently FDA-listed
24 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets43547-0397-11 6,182 Rx · $50,078
100 tablets43547-0397-10 554 Rx · $5,069
10 tablets43547-0397-01 No Medicaid data
30 tablets43547-0397-03 No Medicaid data
50 tablets this page43547-0397-05 No Medicaid data
5000 tablets43547-0397-15 No Medicaid data
500 tablets43547-0397-50 No Medicaid data
Drug total (last 4 qtrs): 6,736 Rx · 262,900 units · $55,147 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
43547-0397-01 10 TABLET in 1 BOTTLE, PLASTIC (43547-397-01) — — 2002-03-29 Active
43547-0397-03 30 TABLET in 1 BOTTLE, PLASTIC (43547-397-03) — — 2002-03-29 Active
43547-0397-05 You're viewing this 50 TABLET in 1 BOTTLE, PLASTIC (43547-397-05) — — 2002-03-29 Active
43547-0397-10 100 TABLET in 1 BOTTLE, PLASTIC (43547-397-10) $0.0117 / ea $1.17 2002-03-29 Active
43547-0397-11 1000 TABLET in 1 BOTTLE, PLASTIC (43547-397-11) $0.0117 / ea $11.65 2002-03-29 Active
43547-0397-15 5000 TABLET in 1 BOTTLE, PLASTIC (43547-397-15) — — 2002-03-29 Active
43547-0397-50 500 TABLET in 1 BOTTLE, PLASTIC (43547-397-50) — — 2002-03-29 Active

You're viewing one of 7 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 1000 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 43547-0397-05?
NDC 43547-0397-05 is a 50-count package — 50 tablet in 1 bottle, plastic.
What is the difference between NDC 43547-0397-05 and NDC 43547-0397-01?
Both are Hydrochlorothiazide 25 mg Tablet — the drug itself is identical. NDC 43547-0397-05 is the 50-count package, while NDC 43547-0397-01 is the 10 tablets package.
What NDC number is used to bill for this package of Hydrochlorothiazide 25 mg Tablet?
Bill NDC 43547-0397-05 — the 11-digit billing format is 43547039705. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 43547-397-05, 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: 43547-0397-05, written without dashes as 43547039705. 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 43547-0397-05, the first segment (43547) is the labeler code FDA assigned to Solco Healthcare U.S., LLC; the middle segment (0397) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Solco Healthcare U.S., LLC. 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 6 other package presentations of this same product, including 10 tablets (43547-0397-01), 30 tablets (43547-0397-03), 100 tablets (43547-0397-10). 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?
Solco Healthcare U.S., LLC 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 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 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 ~3 min read ▾

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

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

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

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

Adults For Edema The usual adult dosage is 25 mg to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

For Control of Hypertension The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS ).

Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

For Edema The usual adult dosage is 25 mg to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

For Control of Hypertension The usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS ). Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

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

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

⛔ Contraindications 11 words ▾

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

⚠️ Warnings ~1 min read ▾

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

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS , Drug Interactions ). Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.

Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

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. Musculoskeletal Muscle spasm. Nervous System/Psychiatric Vertigo, paresthesias, dizziness, headache, restlessness.

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

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

🔄 Drug Interactions 216 words ▾

Drug Interactions When given concurrently the following drugs may interact with thiazide diuretics. Alcohol, barbiturates, or narcotics —potentiation of orthostatic hypotension may occur. Antidiabetic drugs (oral agents and insulin)—dosage adjustment of the antidiabetic drug may be required.

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

Corticosteroids, ACTH —intensified electrolyte depletion, particularly hypokalemia. Pressor amines (e.g., norepinephrine) —possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) —possible increased responsiveness to the muscle relaxant.

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

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

🔄 Drug / Laboratory Test Interactions 19 words ▾

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

🤰 Pregnancy ~1 min read ▾

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.

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 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

🧒 Pediatric Use 67 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 ). Non-melanoma Skin Cancer Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

🆘 Overdosage 104 words ▾

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

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

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

🧬 Clinical Pharmacology 151 words ▾

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

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

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

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

📦 How Supplied / Storage and Handling 170 words ▾

HOW SUPPLIED Hydrochlorothiazide Tablets, USP 25 mg, are peach-colored, round, scored tablets debossed "3571" and "V" on one side. They are supplied as follows: • Bottles of 10: NDC 43547-397-01 • Bottles of 30: NDC 43547-397-03 • Bottles of 50: NDC 43547-397-05 • Bottles of 100: NDC 43547-397-10 • Bottles of 500: NDC 43547-397-50 • Bottles of 1000: NDC 43547-397-11 • Bottles of 5000: NDC 43547-397-15 Hydrochlorothiazide Tablets, USP 50 mg, are peach-colored, round, scored tablets debossed "3572" and "V" on one side.

They are supplied as follows: • Bottles of 10: NDC 43547-398-01 • Bottles of 30: NDC 43547-398-03 • Bottles of 50: NDC 43547-398-05 • Bottles of 100: NDC 43547-398-10 • Bottles of 500: NDC 43547-398-50 • Bottles of 1000: NDC 43547-398-11 You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📦 Storage and Handling 28 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 110 words ▾

DESCRIPTION Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids.

Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral use. Each tablet contains the following inactive ingredients: FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch. This is the structual formula for Hydrochlorothiazide.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43547-0396-10 · Solco 43547-0398-01 · Solco →
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.