Amiodarone hydrochloride 200 mg Tablet, 500-count
by Zydus Lifesciences Limited · 500 TABLET in 1 BOTTLE (65841-631-05)
NDC 65841-0631-05
🏷️ FDA NDC (as labeled)
65841-631-05
billing pads the product segment with a zero
This package
Contains500-count
Pack sizes6 compare ↓
Also priced by: Part D plans $0.2277/unit — full pricing hub ↓
Also comes in:
30 tablets 65841-0631-06
60 tablets 65841-0631-14
100 tablets 65841-0631-30
100 tablets 65841-0631-77
1000 tablets 65841-0631-10
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 Amiodarone Hydrochloride (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 · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0814-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
65841-631-05
Product NDC
65841-631
11-digit billing NDC
65841063105
UNII
976728SY6Z
Application #
ANDA079029
SPL Set ID
3e8db251-e3c5-4fba-be9a-6044a92f0beb
Established class (EPC)
Antiarrhythmic
Mechanism of action
Cytochrome P450 1A2 Inhibitors; Cytochrome P450 2C9 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2009-08-10
Route
ORAL
Dosage form
TABLET
Substance
AMIODARONE HYDROCHLORIDE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 65841-631-05 — 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 → 65841-0631-05. 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 Antiarrhythmic class.
Pharmacologic class
Antiarrhythmic
Drug family (ATC)
Antiarrhythmics, class III
How it works
Cytochrome P450 2D6 Inhibitors, Cytochrome P450 1A2 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 2C9 Inhibitors
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 applicationANDA079029 (ANDA)
Labeler code65841
First marketedAug 2009
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
- Amiodarone is reserved for serious, life-threatening heart rhythms — specifically the kind that can cause sudden cardiac arrest. Doctors only reach for it when other medications ha...
- Why is my doctor putting me on amiodarone instead of something simpler?
- The most important thing is to be consistent. Food significantly increases how much amiodarone your body absorbs, so your doctor will tell you to always take it with food or always...
- Should I take amiodarone with food or on an empty stomach?
Patient education
Supplement & herbal interactions
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 Amiodarone hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White / Yellow
ShapeRound
Imprint2;98
Size13 mm
ScoringScored — splits in 2
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 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 FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your 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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
6 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.
💲 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 | $0.2277 | $113.85 / 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 |
|---|---|---|---|---|---|---|
| Amiodarone Hydrochloride 200 mg 00904-6993-61 | Major | 100 tablets | $0.121 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 29300-0359-05 | Unichem | 500 tablets | $0.121 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 60687-0437-01 | American | 100 tablets | $0.121 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 62135-0577-60 | Chartwell | 60 tablets | $0.121 | AB | Availability likely | — |
| amiodarone hydrochloride 200 mg 68382-0227-05 | Zydus | 500 tablets | $0.121 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 72888-0039-05 | Advagen | 500 tablets | $0.121 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 75907-0006-60 | Dr. | 60 tablets | $0.121 | AB | Availability likely | — |
| Pacerone 200 mg 00245-0147-01 | Upsher-Smith | 100 tablets | $0.125 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 00615-8258-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 00904-7576-61 | Major | 100 tablets | — | AB | FDA listed | — |
| amiodarone hydrochloride 200 mg 48433-0154-20 | Safecor | 100 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 50090-3015-01 | A-S | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 50090-5766-01 | A-S | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 51672-4025-03 | Sun | 1000 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 55154-3365-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 55154-8185-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Amiodarone hydrochloride 200 mgthis 65841-0631-05 | Zydus | 500 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 65862-0732-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 70518-1939-01 | REMEDYREPACK | 90 tablets | — | AB | Discontinued | — |
| Amiodarone Hydrochloride 200 mg 70518-3246-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Amiodarone Hydrochloride 200 mg 70518-3439-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 71335-0881-01 | Bryant | 200 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 71335-1942-01 | Bryant | 200 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 71335-1985-01 | Bryant | 200 tablets | — | AB | FDA listed | — |
| Pacerone 200 mg 71610-0787-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 67296-2296-03 | Redpharm | 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
🏛️
2009
On the market since
Aug 2009
📍
2026
Currently FDA-listed
17 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.
🔬 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 Amiodarone Hydrochloride — the ingredient across all brands.
Top reported reactions
Reporter sex
Male · 61%
Female · 39%
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 |
|---|---|---|---|
| 65841-0631-05 You're viewing this | 500 TABLET in 1 BOTTLE (65841-631-05) | 2009-08-10 | Active |
| 65841-0631-06 | 30 TABLET in 1 BOTTLE (65841-631-06) | 2009-08-10 | Active |
| 65841-0631-10 | 1000 TABLET in 1 BOTTLE (65841-631-10) | 2009-08-10 | Active |
| 65841-0631-14 | 60 TABLET in 1 BOTTLE (65841-631-14) | 2009-08-10 | Active |
| 65841-0631-30 | 10 BLISTER PACK in 1 CARTON (65841-631-30) / 10 TABLET in 1 BLISTER PACK | 2009-08-10 | Active |
| 65841-0631-77 | 10 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK | 2009-08-10 | Active |
Pack size FAQ
What quantity is in NDC 65841-0631-05?
NDC 65841-0631-05 is a 500-count package — 500 tablet in 1 bottle.
What is the difference between NDC 65841-0631-05 and NDC 65841-0631-06?
Both are Amiodarone hydrochloride 200 mg Tablet — the drug itself is identical. NDC 65841-0631-05 is the 500-count package, while NDC 65841-0631-06 is the 30 tablets package.
What NDC number is used to bill for this package of Amiodarone hydrochloride 200 mg Tablet?
Bill NDC 65841-0631-05 — the 11-digit billing format is 65841063105. 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) | ✓ 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 65841-631-05, 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: 65841-0631-05, written without dashes as 65841063105. 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 65841-0631-05, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0631) 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 5 other package presentations of this same product, including 30 tablets (65841-0631-06), 60 tablets (65841-0631-14), 100 tablets (65841-0631-30). 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.