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Bisoprolol Fumarate and Hydrochlorothiazide 5 mg; 6.25 mg Tablet, Film Coated, 100-count — NDC 59651-679-01 (Billing 59651-0679-01)

by Aurobindo Pharma 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 Aurobindo Pharma Limited, marketed since Jan 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 59651-0679-01
🏷️ FDA NDC (as labeled) 59651-679-01 billing pads the product 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 59651-679 · Also comes in: 30 tablets 59651-679-30 500 tablets 59651-679-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 59651-679-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59651 labeler · 679 product · 01 package
Package marketed since
Jan 21, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5965167901 2
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Bisoprolol Fumarate And Hydrochlorothiazide (different manufacturers) — 1 · 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
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) 59651-679-01
Product NDC 59651-679
11-digit billing NDC 59651067901
Application # ANDA217922
SPL Set ID e9aaa10f-eb85-40a2-bc1e-f4031fbebe3b
Established class (EPC) Thiazide Diuretic; beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
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 2026-01-21
Route ORAL
Dosage form TABLET, FILM COATED
Substance BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 59651-679-01 — 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 → 59651-0679-01. 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.

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
59651-0679-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2026-01-21 — Active
59651-0679-05 59651-679-05 500 TABLET, FILM COATED in 1 BOTTLE 2026-01-21 — Active
59651-0679-30 59651-679-30 30 TABLET, FILM COATED in 1 BOTTLE 2026-01-21 — 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 59651-0679-30?
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 59651-0679-30 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 mgthis 59651-0679-01 Aurobindo 100 tablets — AB FDA listed —
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg/1; 6.25 mg 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA217922 (ANDA)
Labeler code59651
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio1,464 products on file

More NDCs from Aurobindo Pharma Limited labeler code 59651

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Aurobindo Pharma 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 (59651-0679-30), 500 tablets (59651-0679-05). 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?
Aurobindo Pharma 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.
← 59651-0678-01 · Aurobindo 59651-0680-01 · Aurobindo →
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.