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Carvedilol 3.125 mg Tablet, Film Coated, 500-count — NDC 65841-0616-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Carvedilol 3.125 mg Tablet, Film Coated, 500-count — NDC 65841-616-05 (Billing 65841-0616-05)

by Zydus Lifesciences Limited · 500 TABLET, FILM COATED in 1 BOTTLE

This is a package of 500 tablets of Carvedilol 3.125 mg Tablet, Film Coated from Zydus Lifesciences Limited, marketed since Sep 2007 and currently FDA-listed.

NDC 65841-0616-05
🏷️ FDA NDC (as labeled) 65841-616-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.0650/unit — full pricing hub ↓
Product page 65841-0616-01 Also comes in: 28 tablets 65841-616-17 100 tablets 65841-616-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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 65841-616-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65841 labeler · 616 product · 05 package
Package marketed since
Sep 5, 2007
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0368382092014, 0368382093011, 0368382094018
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Carvedilol (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 20, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0594-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0578-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0577-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0579-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0588-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0587-2025
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) 65841-616-05
Product NDC 65841-616
11-digit billing NDC 65841061605
RxCUI 200031, 200032, 200033, 686924
UNII 0K47UL67F2
UPC 0368382092014, 0368382093011, 0368382094018
Application # ANDA077614
SPL Set ID 29082d8c-bbde-4620-924f-02dcf1764919
Established class (EPC) alpha-Adrenergic Blocker; beta-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists; Adrenergic beta1-Antagonists; Adrenergic beta2-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-05
Route ORAL
Dosage form TABLET, FILM COATED
Substance CARVEDILOL
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 200031
Why two NDCs? The FDA registers this code as 65841-616-05 — 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 → 65841-0616-05. 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 alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker, beta-Adrenergic Blocker
Drug family (ATC) Alpha and beta blocking agents
How it works Adrenergic alpha-Antagonists, Adrenergic beta1-Antagonists, Adrenergic beta2-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

Carvedilol is used to treat heart failure (condition in which the heart cannot pump enough blood to all parts of the body) and high blood pressure. It also is used to improve survival after a heart attack.  Carvedilol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Food slows how fast the medicine is absorbed. That lowers the chance of dizziness or lightheadedness when you stand up. It doesn't change how much of the drug your body takes in, s...
  • Why do I need to take Carvedilol with food?
  • No. Stopping suddenly can make chest pain worse and has led to heart attacks and dangerous heart rhythms, even in people who may not know they have heart disease. If you need to st...
  • It can, especially when you first start or when the dose goes up. Dizziness is the most common side effect. Until you know how it affects you, be careful with driving or hazardous...
📖 Read our full Carvedilol guide →
1
Nutrient depletion considerations

Carvedilol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Carvedilol nutrient depletion report →
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.

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 $0.0650 $32.50 / 500 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
65841-0616-01 65841-616-01 Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2007-09-05 — Active
65841-0616-05 You're viewing this 500 TABLET, FILM COATED in 1 BOTTLE 2007-09-05 — Active
65841-0616-17 65841-616-17 28 TABLET, FILM COATED in 1 BOTTLE 2007-09-05 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, film coated in 1 bottle.
How does this package differ from NDC 65841-0616-17?
Both are Carvedilol 3.125 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 65841-0616-17 is the 28 tablets package.
What NDC number is used to bill for this package of Carvedilol 3.125 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
Carvedilol 3.125 mg 00093-0051-01 Teva 100 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 00781-5221-01 Sandoz 100 tablets $0.017 AB Discontinued —
Carvedilol 3.125 mg 00904-7305-61 Major 1 tablet $0.017 AB Availability likely —
Carvedilol 3.125 mg 65862-0142-01 Aurobindo 100 tablets $0.017 — Availability likely —
Carvedilol 3.125 mg 68001-0153-00 BluePoint 100 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 68382-0092-01 Zydus 100 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 68462-0162-01 Glenmark 100 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 72888-0034-00 Advagen 1000 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 72888-0499-01 Advagen 100 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 82009-0125-05 Quallent 500 tablets $0.017 AB Availability likely —
Carvedilol 3.125 mg 00615-8387-30 NCS 5 tablets — AB Discontinued —
Carvedilol 3.125 mg 42708-0072-60 QPharma, 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 42708-0181-60 QPharma 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 43063-0126-60 PD-Rx 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 50090-1062-00 A-S 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 50090-6949-00 A-S 90 tablets — AB FDA listed —
Carvedilol 3.125 mg 50090-7890-00 A-S 90 tablets — AB FDA listed —
Carvedilol 3.125 mg 51407-0039-01 Golden 100 tablets — AB FDA listed —
Carvedilol 3.125 mg 51655-0034-25 Northwind 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 51655-0713-25 Northwind 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 55111-0252-01 Dr. 100 tablets — AB FDA listed —
Carvedilol 3.125 mg 55154-2641-00 Cardinal 1 tablet — AB FDA listed —
Carvedilol 3.125 mg 58657-0750-01 Method 100 tablets — AB FDA listed —
Carvedilol 3.125 mg 63187-0570-30 Proficient 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 63187-0941-30 Proficient 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 63629-4060-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 3.125 mgthis 65841-0616-05 Zydus 500 tablets — AB FDA listed —
Carvedilol 3.125 mg 67046-1616-03 Coupler 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 68071-3138-03 NuCare 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 68071-3970-06 NuCare 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 68788-8252-01 Preferred 100 tablets — AB FDA listed —
Carvedilol 3.125 mg 70518-1377-00 REMEDYREPACK 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 71335-1128-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 71335-1407-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 3.125 mg 71610-0062-53 Aphena 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 71610-0132-53 Aphena 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 72189-0653-90 Direct_Rx 90 tablets — AB FDA listed —
Carvedilol 3.125 mg 72789-0411-90 PD-Rx 90 tablets — AB FDA listed —
Carvedilol 3.125 mg 76385-0110-01 UNICHEM 100 tablets — AB FDA listed —
Coreg 3.125 mg 80725-0139-20 Waylis 100 tablets — AB FDA listed —
Carvedilol 3.125 mg 82804-0191-60 Proficient 60 tablets — AB FDA listed —
Carvedilol 3.125 mg 67046-0973-03 Coupler 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

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 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 White
ShapeRound
ImprintZC42
Size10 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.

🧪 Avoiding an ingredient? See Carvedilol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

9 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 holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA077614 (ANDA)
Labeler code65841
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 65841

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 87 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-616-01 in bottle of 100 Tablets Carvedilol Tablets USP, 3.125 mg R x only 100 Tablets NDC 65841-617-01 in bottle of 100 Tablets Carvedilol Tablets USP, 6.25 mg R x only 100 Tablets NDC 65841-618-01 in bottle of 100 Tablets Carvedilol Tablets USP, 12.5 mg R x only 100 Tablets NDC 65841-619-01 in bottle of 100 Tablets Carvedilol Tablets USP, 25 mg R x only 100 Tablets Carvedilol Tablets, 3.125 mg Carvedilol Tablets, 6.25 mg Carvedilol Tablets, 12.5 mg Carvedilol Tablets,25 mg

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Carvedilol — the program that covers self-administered drugs. 15 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 Carvedilol. 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
$36.64M
Claims incl. refills
3.9M
Beneficiaries
2.8M
Spend / beneficiary
$12.90
Spend / claim
$9.29
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.

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 28 tablets (65841-0616-17), 100 tablets (65841-0616-01). 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.
← 65841-0614-01 · Zydus 65841-0617-01 · 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.