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Bisoprolol Fumarate and Hydrochlorothiazide 5 mg; 6.25 mg Tablet, Film Coated, 100-count — NDC 70771-1761-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bisoprolol Fumarate and Hydrochlorothiazide 5 mg; 6.25 mg Tablet, Film Coated, 100-count — NDC 70771-1761-1 (Billing 70771-1761-01)

by Zydus Lifesciences Limited · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Bisoprolol Fumarate and Hydrochlorothiazide 5 mg; 6.25 mg Tablet, Film Coated from Zydus Lifesciences Limited, marketed since Mar 2023 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 70771-1761-01
🏷️ FDA NDC (as labeled) 70771-1761-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.4132/unit — full pricing hub ↓
Main listing for product 70771-1761 · Also comes in: 30 tablets 70771-1761-3 500 tablets 70771-1761-5
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 70771-1761-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1761 product · 1 package
Package marketed since
Mar 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077117611 3
FDA record last changed
Oct 1, 2026
⚠️
Other active recalls for Bisoprolol Fumarate And Hydrochlorothiazide (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 21, 2026 — cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. (Unichem Pharmaceuticals USA Inc.) · FDA recall D-0301-2026
Class III · Nov 21, 2025 — Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0199-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1761-1
Product NDC 70771-1761
11-digit billing NDC 70771176101
RxCUI 854908, 854916, 854919
UNII 0J48LPH2TH, UR59KN573L
Application # ANDA215666
SPL Set ID 35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa
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 2023-03-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 854908
Why two NDCs? The FDA registers this code as 70771-1761-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70771-1761-01. 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 beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, selective
How it works Adrenergic beta-Antagonists
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.

Clinical

📖 What it is MedlinePlus · NLM

Bisoprolol is used to treat high blood pressure. Bisoprolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve and decrease blood pressure.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 $0.4132 $41.32 / 100 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1761-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2023-03-01 — Active
70771-1761-03 70771-1761-3 30 TABLET, FILM COATED in 1 BOTTLE 2023-03-01 — Active
70771-1761-05 70771-1761-5 500 TABLET, FILM COATED in 1 BOTTLE 2023-03-01 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 70771-1761-03?
Both are Bisoprolol Fumarate and Hydrochlorothiazide 5 mg; 6.25 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 70771-1761-03 is the 30 tablets package.
What NDC number is used to bill for this package of Bisoprolol Fumarate and Hydrochlorothiazide 5 mg; 6.25 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
bisoprolol fumarate and hydrochlorothiazide 5 mg/1; 6.25 mg 00093-3242-01 Teva 100 tablets $0.220 — Availability likely —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 00378-0503-01 Mylan 100 tablets $0.220 AB Availability likely —
bisoprolol fumarate and hydrochlorothiazide 6.25 mg/1; 5 mg 29300-0188-01 Unichem 100 tablets $0.220 AB Availability likely —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 42799-0921-01 Edenbridge 100 tablets $0.220 AB Availability likely —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 68462-0879-01 GLENMARK 100 tablets $0.220 AB Availability likely —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 72578-0114-01 Viona 100 tablets $0.220 AB Availability likely —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 70954-0413-10 ANI 30 tablets $0.234 AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 10135-0741-01 Marlex 100 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 50090-6413-00 A-S 30 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 50090-7357-00 A-S 30 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 59651-0679-01 Aurobindo 100 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mgthis 70771-1761-01 Zydus 100 tablets — AB FDA listed —
bisoprolol fumarate and hydrochlorothiazide 6.25 mg/1; 5 mg 71335-0595-01 Bryant 30 tablets — AB Discontinued —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 71335-1769-01 Bryant 30 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 71335-2589-01 Bryant 30 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 50090-5849-00 A-S 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow / Pink / White
ShapeRound
Imprint115
Size7 mm
ScoringNot scored
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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII 40UAA97IT9
    Crospovidone is a synthetic polymer derived from povidone. It absorbs liquid quickly and swells, helping tablets and capsules break apart and dissolve faster in your stomach.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

12 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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderCADILA HEALTHCARE LTD
FDA applicationANDA215666 (ANDA)
Labeler code70771
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

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.

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 61 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1760-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg/6.25 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1761-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg 30 Tablets Unit-of-Use Rx only NDC 70771-1762-3 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg 30 Tablets Unit-of-Use Rx only 2.5 mg/6.25 mg 5 mg/6.25 mg 10 mg/6.25 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Bisoprolol fumarate and hydrochlorothiazide — the ingredient across all brands.

Top reported reactions

Headache50
Fatigue44
Nausea41
Pruritus39
Pain38
Hypertension37
Vomiting36

Age at onset

Child1
Adult16
Elderly10

Reporter sex

615 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization263
Death53
Life-threatening38
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 15 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.

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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Zydus Lifesciences Limited. 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 2 other package presentations of this same product, including 30 tablets (70771-1761-03), 500 tablets (70771-1761-05). 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?
Zydus Lifesciences Limited 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.
← 70771-1760-01 · Zydus 70771-1762-01 · Zydus →
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.