HomeNDC LookupIngredientsHydrochlorothiazide › 69584-0361-90
Hydrochlorothiazide 25 mg Tablet, 1,000-count — NDC 69584-0361-90 package photo

Hydrochlorothiazide 25 mg Tablet, 1,000-count

by Oxford Pharmaceuticals, LLC · 1000 TABLET in 1 BOTTLE (69584-361-90)
NDC 69584-0361-90
🏷️ FDA NDC (as labeled) 69584-361-90 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0117 NADAC Per package$11.70 / 1000 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.1406/unit · Part D plans $0.0822/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 69584-361-90
Product NDC 69584-361
11-digit billing NDC 69584036190
NCPDP billing unit EA — each (per item)
RxCUI 197770, 310798
UNII 0J48LPH2TH
Application # ANDA087059
SPL Set ID afbb9a0e-c22f-4133-8015-b4b2ab4d32e6
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 2020-09-25
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 69584-361-90 — 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 → 69584-0361-90. 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

LabelerOxford Pharmaceuticals, LLC
Application holderOXFORD PHARMACEUTICALS LLC
FDA applicationANDA087059 (ANDA)
Labeler code69584
First marketedSep 2020
Product typeHuman Prescription Drug
Portfolio35 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.

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
Imprint362;O
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.

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

Inactive ingredient FAQ

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

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.012 $11.70 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.1406 $140.60 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.0822 $82.20 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.014 $0.012
▼ Down 19% over the last 24 months.
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 mgthis 69584-0361-90 Oxford 1000 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 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69584-0361-90, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
69.7K
Units reimbursed last 4 qtrs
2.5M
Gross reimbursed last 4 qtrs
$358.3K
Avg / prescription
$5.14
Avg / unit
$0.1406
Latest quarter Q4 2025
19.1KRx
Medicaid pays / ea
$0.1406
gross reimbursed
vs
NADAC / ea
$0.0117
acquisition cost
=
Spread
+$0.1289
+1102% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
25% FFS 75% MCO
Fee-for-service · 17,552 Rx Managed care · 52,104 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,351 units · 17.3 per 100k residents WA Idaho: 1,763 units · 89.8 per 100k residents ID Montana: no data reported MT North Dakota: 1,040 units · 133 per 100k residents ND Minnesota: 8,884 units · 155 per 100k residents MN Wisconsin: 18,796 units · 318 per 100k residents WI Michigan: 53,264 units · 531 per 100k residents MI New York: 437,419 units · 2,235 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,080 units · 25.5 per 100k residents OR Nevada: 4,905 units · 154 per 100k residents NV Wyoming: no data reported WY South Dakota: 480 units · 52.2 per 100k residents SD Iowa: 5,292 units · 165 per 100k residents IA Illinois: 53,009 units · 422 per 100k residents IL Indiana: 9,706 units · 141 per 100k residents IN Ohio: 20,341 units · 173 per 100k residents OH Pennsylvania: 94,785 units · 731 per 100k residents PA New Jersey: 98,535 units · 1,061 per 100k residents NJ Massachusetts: no data reported MA California: 180,804 units · 464 per 100k residents CA Utah: no data reported UT Colorado: 9,728 units · 165 per 100k residents CO Nebraska: 2,644 units · 134 per 100k residents NE Missouri: 13,534 units · 218 per 100k residents MO Kentucky: 15,939 units · 352 per 100k residents KY West Virginia: 16,731 units · 945 per 100k residents WV Virginia: 21,430 units · 246 per 100k residents VA Maryland: 26,728 units · 432 per 100k residents MD Connecticut: 80,231 units · 2,218 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 1,350 units · 63.9 per 100k residents NM Kansas: no data reported KS Arkansas: 5,184 units · 169 per 100k residents AR Tennessee: 6,101 units · 85.6 per 100k residents TN North Carolina: 25,528 units · 236 per 100k residents NC South Carolina: 3,960 units · 73.7 per 100k residents SC Delaware: 3,210 units · 311 per 100k residents DE Oklahoma: 2,360 units · 58.2 per 100k residents OK Louisiana: 17,789 units · 389 per 100k residents LA Mississippi: 675 units · 23.0 per 100k residents MS Alabama: 5,516 units · 108 per 100k residents AL Georgia: 6,700 units · 60.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 13,874 units · 45.5 per 100k residents TX Florida: 77,750 units · 344 per 100k residents FL
Units reimbursed · per 100k residents
17.32,235
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 2,235 /100k
2 Connecticut 2,218 /100k
3 New Jersey 1,061 /100k
4 West Virginia 945 /100k
5 Pennsylvania 731 /100k
6 Michigan 531 /100k
7 California 464 /100k
8 Maryland 432 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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 tablets this page69584-0361-90 69,656 Rx · $358,263
100 tablets69584-0361-10 2,690 Rx · $20,109
5000 tablets69584-0361-95 1,824 Rx · $13,777
Drug total (last 4 qtrs): 74,170 Rx · 2,727,036 units · $392,149 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
69584-0361-10 100 TABLET in 1 BOTTLE (69584-361-10) $0.0117 / ea $1.17 2020-09-25 Active
69584-0361-90 You're viewing this 1000 TABLET in 1 BOTTLE (69584-361-90) $0.0117 / ea $11.65 2020-09-25 Active
69584-0361-95 5000 TABLET in 1 BOTTLE (69584-361-95) $0.0117 / ea $58.25 2020-09-25 Active

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

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0117 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 94% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69584-0361-90?
NDC 69584-0361-90 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 69584-0361-90 and NDC 69584-0361-10?
Both are Hydrochlorothiazide 25 mg Tablet — the drug itself is identical. NDC 69584-0361-90 is the 1,000-count package, while NDC 69584-0361-10 is the 100 tablets package.
What NDC number is used to bill for this package of Hydrochlorothiazide 25 mg Tablet?
Bill NDC 69584-0361-90 — the 11-digit billing format is 69584036190. 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.

📄 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 79 words

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 has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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.

⏱️ Dosage and Administration ~1 min read

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 ). HOW SUPPLIED

Contraindications 11 words

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

⚠️ Warnings 210 words

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

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

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

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

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

🤒 Adverse Reactions ~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. 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.

🔄 Drug Interactions 220 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.

Nonsteroidal 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

🔄 Drug / Laboratory Test Interactions 21 words

Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, Genera l ). Carcinogenesis, Mutagenesis, Impairment of Fertility

👥 Use in Specific Populations 199 words

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 107 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 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 hiazides 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. Nursing Mothers

🆘 Overdosage 107 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. DOSAGE AND ADMINISTRATION

🧬 Clinical Pharmacology ~2 min read

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. 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 has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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.

📦 How Supplied / Storage and Handling 112 words

Hydrochlorothiazide Tablets, USP are supplied as follows: 25 mg - Peach, round scored tablets, upper debossed with "361" above bisect and lower debossed "O". Available in bottles of: 100, NDC 69584-361-10 1000, NDC 69584-361-90 5000, NDC 69584-361-95 50 mg - Peach, round scored tablets, upper debossed with "362" above bisect and lower debossed "O". Available in bottles of: 100, NDC 69584-362-10 1000, NDC 69584-362-90.

Store at: 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211 8200020 Revised: 12/2024 R01

📋 Description 98 words

DESCRIPTION Hydrochlorothiazide, USP 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-sulfonamide1,1-dioxide, and its structural formula is C 7 H 8 ClN 3 O 4 S 2 M.W.

297.74 Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, pregelatinized starch from corn, magnesium stearate, microcrystalline cellulose, and FD&C Yellow #6.

💬 Information for Patients 68 words

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

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 ).

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