Quick answers
- What is Hydrochlorothiazide used for?
- The FDA-approved label (Inzirqo, ANI Pharmaceuticals, Inc., December 16, 2025) says: “INZIRQO™ (hydrochlorothiazide) is a thiazide diuretic indicated for: The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydrochlorothiazide have a boxed warning?
- No. None of the 132 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydrochlorothiazide?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 19, 2025). Ask your pharmacist about alternatives.
- Has Hydrochlorothiazide been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started August 21, 2018 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Hydrochlorothiazide?
- 41 companies list prescription products of Hydrochlorothiazide in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Proficient Rx LP.
What Hydrochlorothiazide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INZIRQO™ (hydrochlorothiazide) is a thiazide diuretic indicated for: The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. …
— FDA label: Inzirqo, ANI Pharmaceuticals, Inc., effective December 16, 2025. Read the full label on DailyMed →
The FDA has 132 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 132 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Capsule · Capsule, gelatin coated · Solution · Powder, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 171 in the FDA NDC Directory |
| Brand names | Inzirqo |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydrochlorothiazide 10 mg/mL powder, for suspension | Brand: Inzirqo | $4.47 per mL |
| hydrochlorothiazide 12.5 mg capsule | Generic | $0.0272 per capsule |
| hydrochlorothiazide 12.5 mg capsule, gelatin coated | Generic | $0.0272 per capsule |
| hydrochlorothiazide 12.5 mg tablet | Generic | $0.0358 per tablet |
| hydrochlorothiazide 25 mg tablet | Generic | $0.0114 per tablet |
| hydrochlorothiazide 50 mg tablet | Generic | $0.0312 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions21 products
- Bryant Ranch Prepack17 products
- Proficient Rx LP15 products
- Northwind Health Company, LLC11 products
- NuCare Pharmaceuticals, Inc.11 products
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Remedyrepack Inc.9 products
- Preferred Pharmaceuticals Inc.6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- QPharma, Inc.5 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Aurobindo Pharma Limited3 products
- Leading Pharma, LLC3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- American Health Packaging3 products
- Teva Pharmaceuticals USA, Inc.3 products
- ScieGen Pharmaceuticals, Inc.3 products
- Golden State Medical Supply, Inc.3 products
- Accord Healthcare Inc.3 products
- Chartwell RX, LLC3 products
- Exelan Pharmaceuticals Inc.2 products
- Oxford Pharmaceuticals, LLC2 products
- Actavis Pharma, Inc.2 products
- St. Mary's Medical Park Pharmacy2 products
- Redpharm Drug2 products
- Direct_Rx2 products
- Solco Healthcare U.S., LLC2 products
- Quality Care Products, LLC1 product
- Legacy Pharmaceutical Packaging, LLC1 product
- Advagen Pharma Ltd1 product
- Alembic Pharmaceuticals Limited1 product
- Lake Erie Medical DBA Quality Care Products LLC1 product
- Unit Dose Solutions, Inc.1 product
- Teva Pharmaceuticals, Inc.1 product
- Coupler LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Westminster Pharmaceuticals, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- AvPAK1 product
- Alembic Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020504 MICROZIDE | Teva Branded Pharm | December 27, 1996 | 6, latest August 20, 2020 2020: Labeling · 2017: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA219141 INZIRQO | Novitium Pharma | January 28, 2025 | — |
Generic approvals (16)
- ANDA083177Ivax Sub Teva Pharms · January 12, 1973
- ANDA085182Heritage · January 20, 1978
- ANDA087059Oxford Pharms · November 5, 1980
- ANDA087068Oxford Pharms · November 5, 1980
- ANDA040412Prinston Inc · March 29, 2002
- ANDA040707Actavis Elizabeth · February 27, 2007
- ANDA040702Leading · March 16, 2007
- ANDA040780Aurobindo Pharma · July 20, 2007
- ANDA078164Aurobindo Pharma · September 19, 2007
- ANDA040907Unichem · August 15, 2008
- ANDA090510Unichem · January 19, 2010
- ANDA200645Alembic Pharms Ltd · November 30, 2010
- ANDA202556Accord Hlthcare · September 24, 2012
- ANDA203018Sciegen Pharms · July 23, 2014
- ANDA203561Sciegen Pharms · January 14, 2019
- ANDA218248Rubicon Research · October 7, 2026
Shortage status
To be discontinued · updated November 19, 2025 · first posted November 19, 2025
| Product | Microzide, Capsule, 12.5 mg (NDC 0591-0347-01) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 21, 2018 · Class I · Terminated · D-1206-2018
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182- — Accord Healthcare, Inc.
-
July 30, 2015 · Class II · Terminated · D-1352-2015
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Roche — Unichem Pharmaceuticals Usa Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Inzirqo, ANI Pharmaceuticals, Inc., effective December 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →