Carvedilol 12.5 mg Tablet, Film Coated, 500-count
by Zydus Lifesciences Limited · 500 TABLET, FILM COATED in 1 BOTTLE (65841-618-05)
NDC 65841-0618-05
🏷️ FDA NDC (as labeled)
65841-618-05
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 ↓
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
65841-618-05
Product NDC
65841-618
11-digit billing NDC
65841061805
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
Why two NDCs?
The FDA registers this code as 65841-618-05 — 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 → 65841-0618-05. 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.
🏭 Manufacturer & labeler
LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA077614 (ANDA)
Labeler code65841
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio717 products on file
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.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- Carvedilol works by blocking two sets of receptors — beta-receptors and alpha-1 receptors — in your heart and blood vessels. This slows your heart rate, reduces how hard your heart...
- What is carvedilol actually doing for my heart?
- Taking carvedilol with food slows down how quickly it's absorbed into your bloodstream. That matters because one of its side effects is dizziness or a drop in blood pressure when y...
- Please don't stop carvedilol suddenly without talking to your doctor first — this is one of the most important things to know about this medication. Abruptly stopping it, especiall...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Carvedilol — tap one for details:
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.
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.
💬 Questions about Carvedilol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeRound
ImprintZC42
Size1 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.
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.
💲 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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Carvedilol 12.5 mg 00781-5223-01 | Sandoz | 100 tablets | $0.021 | AB | Discontinued | — |
| Carvedilol 12.5 mg 00093-7295-01 | Teva | 100 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 00904-7307-61 | Major | 1 tablet | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 65862-0144-01 | Aurobindo | 100 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 68001-0151-00 | BluePoint | 100 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 68382-0094-01 | Zydus | 100 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 68462-0164-01 | Glenmark | 100 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 72888-0036-00 | Advagen | 1000 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 72888-0501-01 | Advagen | 100 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 82009-0127-05 | Quallent | 500 tablets | $0.021 | AB | Availability likely | — |
| Carvedilol 12.5 mg 00615-8389-30 | NCS | 5 tablets | — | AB | Discontinued | — |
| Carvedilol 12.5 mg 43063-0125-93 | PD-Rx | 180 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 50090-1067-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 50090-2079-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 50090-6878-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 51407-0041-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 51655-0030-25 | Northwind | 60 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 55111-0254-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 55154-2648-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 58657-0752-01 | Method | 100 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 60760-0494-60 | St. | 60 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 63187-0447-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mgthis 65841-0618-05 | Zydus | 500 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 67046-0879-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 68071-2230-06 | NuCare | 60 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 68788-7539-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 70518-0356-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 70518-4389-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 71335-1533-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 71335-1545-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 71335-1813-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 71335-2026-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 71610-0066-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 72189-0372-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 72789-0537-93 | PD-Rx | 180 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 76385-0112-01 | UNICHEM | 100 tablets | — | AB | FDA listed | — |
| Coreg 12.5 mg 80725-0141-20 | Waylis | 100 tablets | — | AB | FDA listed | — |
| Carvedilol 12.5 mg 82804-0225-90 | Proficient | 90 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.
📊 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.
🔬 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 Carvedilol — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 53%
Female · 47%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65841-0618-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-618-01) | 2007-09-05 | Active |
| 65841-0618-05 You're viewing this | 500 TABLET, FILM COATED in 1 BOTTLE (65841-618-05) | 2007-09-05 | Active |
| 65841-0618-17 | 28 TABLET, FILM COATED in 1 BOTTLE (65841-618-17) | 2007-09-05 | Active |
You're viewing the largest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 65841-0618-05?
NDC 65841-0618-05 is a 500-count package — 500 tablet, film coated in 1 bottle.
What is the difference between NDC 65841-0618-05 and NDC 65841-0618-17?
Both are Carvedilol 12.5 mg Tablet, Film Coated — the drug itself is identical. NDC 65841-0618-05 is the 500-count package, while NDC 65841-0618-17 is the 28 tablets package.
What NDC number is used to bill for this package of Carvedilol 12.5 mg Tablet, Film Coated?
Bill NDC 65841-0618-05 — the 11-digit billing format is 65841061805. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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) | — 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 FDA registers it as 65841-618-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65841-0618-05, written without dashes as 65841061805. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65841-0618-05, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0618) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
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 (65841-0618-17), 100 tablets (65841-0618-01). 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.
📄 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 ▾
No readable label sections were found for this product.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.