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Prescription medicine

Bisoprolol and hydrochlorothiazide First approved as Ziac

Bisoprolol and hydrochlorothiazide (Ziac) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.209 per bisoprolol-hydrochlorothiazide 10-6.25 mg tablet in the October 7, 2026 NADAC survey.

  • Generic listed

Check it at the source: the bisoprolol and hydrochlorothiazide FDA label on DailyMed (effective August 11, 2026, Teva Pharmaceuticals USA, Inc.); the NDA 20186 record on Drugs@FDA; every bisoprolol and hydrochlorothiazide label on DailyMed.

Highlights of the record

FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.

Forms and strengths

  • 2.5 mg / 6.25 mg
  • 5 mg / 6.25 mg
  • 6.25 mg / 5 mg
  • 6.25 mg / 2.5 mg
  • 6.25 mg / 10 mg
  • 10 mg / 6.25 mg

Film-coated tablet; tablet.

On the market

Earliest approval on file
March 26, 1993 Ziac, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
15 first September 25, 2000; 9 with a marketed status in Drugs@FDA
Labelers listed (NDC)
12 of which 11 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.209 per tablet Bisoprolol-hydrochlorothiazide 10-6.25 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
4 since 2021 0 Class I among all firms' recalls; latest January 21, 2026
FAERS reports
614 through July 30, 2026

What is bisoprolol and hydrochlorothiazide used for?

From the label: indications and usage

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.

Conditions named in the indications of bisoprolol and hydrochlorothiazide's FDA labels, with every medicine labeled for each:

From other bisoprolol and hydrochlorothiazide labels

High blood pressure: INDICATIONS AND USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.

FDA pharmacologic class: Thiazide Diuretic and beta-Adrenergic Blocker.

Source: FDA drug label (bisoprolol fumarate and hydrochlorothiazide), Teva Pharmaceuticals USA, Inc., effective August 11, 2026 (SPL set 27d52b23-e3e2-4339-b00e-cd0fec43ffbb), via openFDA; the full label on DailyMed

Is there a generic for bisoprolol and hydrochlorothiazide (Ziac)?

The FDA approved the first generic bisoprolol and hydrochlorothiazide on September 25, 2000. 15 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists bisoprolol and hydrochlorothiazide from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1993 earliest approval on file
  • 2000 first generic approved
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for bisoprolol and hydrochlorothiazide (Ziac)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.209 per Bisoprolol-hydrochlorothiazide 10-6.25 mg tablet, up 3% from $0.204 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Bisoprolol-hydrochlorothiazide 10-6.25 mg tablet (generic)
$0.280
$0.123
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Bisoprolol-hydrochlorothiazide 10-6.25 mg tabletGeneric$0.209 per tablet$6.28+3%
Bisoprolol-hydrochlorothiazide 2.5-6.25 mg tabletGeneric$0.213 per tablet$6.40+3%
Bisoprolol-hydrochlorothiazide 5-6.25 mg tabletGeneric$0.220 per tablet$6.61+11%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has bisoprolol and hydrochlorothiazide been recalled?

The FDA's Enforcement Report lists 4 recalls naming bisoprolol and hydrochlorothiazide since 2021: 0 Class I (the most serious), 2 Class II, 2 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
January 21, 2026Class IIUnichem Pharmaceuticals USA Inc.cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
November 21, 2025Class IIIGlenmark Pharmaceuticals Inc., USACross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
October 20, 2023Class IIIGlenmark Pharmaceuticals Inc., USAFailed Impurities/Degradation Specifications
March 15, 2021Class IICardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the bisoprolol and hydrochlorothiazide label say about other medicines?

The bisoprolol and hydrochlorothiazide label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Clonidinedrug interactionsIn patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that bisoprolol fumarate and hydrochlorothiazide tablets be discontinued for several days before the withdrawal of clonidine.
Diltiazemdrug interactionsBisoprolol fumarate and hydrochlorothiazide tablets should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are …
Disopyramidedrug interactions… the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Verapamildrug interactionsBisoprolol fumarate and hydrochlorothiazide tablets should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are …

Check bisoprolol and hydrochlorothiazide against other medicines

Source: FDA drug label (bisoprolol fumarate and hydrochlorothiazide), Teva Pharmaceuticals USA, Inc., effective August 11, 2026 (SPL set 27d52b23-e3e2-4339-b00e-cd0fec43ffbb), via openFDA; the full label on DailyMed

What do FAERS reports show for bisoprolol and hydrochlorothiazide?

The FDA Adverse Event Reporting System holds 614 reports that list bisoprolol and hydrochlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 262 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Headache (named in the label)50
  • Fatigue (named in the label)44
  • Drug Ineffective (a use or a product term, not a reaction)42
  • Nausea (named in the label)41
  • Pruritus (named in the label)39
  • Pain38
  • Hypertension (a use or a product term, not a reaction)37
  • Vomiting (named in the label)36

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as bisoprolol and hydrochlorothiazide?

59 other medicines are given the same way (oral) and in the same FDA class as bisoprolol and hydrochlorothiazide or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
MetoprololHigh blood pressure64 labelers$0.085 per tablet 100 mg tabletA presentation being discontinued
PropranololHigh blood pressure38 labelers$0.0493 per tablet 20 mg tabletIn shortage
CarvedilolHigh blood pressure41 labelers$0.0179 per tablet 6.25 mg tabletNo current entry
AtenololHigh blood pressure35 labelers$0.0217 per tablet 25 mg tabletNo current entry
LabetalolHigh blood pressure31 labelers$0.215 per tablet 300 mg tabletNo current entry
NebivololHigh blood pressure23 labelers$0.141 per tablet 10 mg tabletA presentation being discontinued
NadololHigh blood pressure16 labelers$0.147 per tablet 20 mg tabletNo current entry
PindololHigh blood pressure8 labelers$0.854 per tablet 10 mg tabletA presentation being discontinued

Every medicine labeled for the same conditions as bisoprolol and hydrochlorothiazide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Other thiazide diuretics
the pharmacologic class, with prices and generics
Bisoprolol and hydrochlorothiazide side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other