Home › NDC Lookup › Ingredients › Amiodarone Hydrochloride › 65841-0631-14
Amiodarone hydrochloride 200 mg Tablet, 60-count — NDC 65841-0631-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amiodarone hydrochloride 200 mg Tablet, 60-count — NDC 65841-631-14 (Billing 65841-0631-14)

by Zydus Lifesciences Limited · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Amiodarone hydrochloride 200 mg Tablet from Zydus Lifesciences Limited, marketed since Aug 2009 and currently FDA-listed.

NDC 65841-0631-14
🏷️ FDA NDC (as labeled) 65841-631-14 billing pads the product segment with a zero
This package
Contains60-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.2277/unit — full pricing hub ↓
Product page 65841-0631-05 Also comes in: 30 tablets 65841-631-06 100 tablets 65841-631-30 100 tablets 65841-631-77 500 tablets 65841-631-05 1000 tablets 65841-631-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 65841-631-14 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65841 labeler · 631 product · 14 package
Package marketed since
Aug 10, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6584163114 2
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65841-631-14
Product NDC 65841-631
11-digit billing NDC 65841063114
RxCUI 833528, 834348, 835956
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
Quick answers
  • RxCUI (RxNorm): 833528
Why two NDCs? The FDA registers this code as 65841-631-14 — 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 → 65841-0631-14. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats life-threatening ventricular rhythm problems, specifically ventricular fibrillation and unstable ventricular tachycardia. It is usually used when other heart rhythm medic...
  • Take them the same way with respect to meals each day. Your prescriber may start you on a higher loading amount and then lower it. If the daily total is high or your stomach is ups...
  • Call right away for a new cough, shortness of breath, fever, yellow skin or eyes, dark urine, fainting, a very slow or irregular heartbeat, or vision changes. These can signal lung...
  • No, avoid it. Grapefruit juice raises amiodarone levels in your body. Also check with me before starting any new medicine, since amiodarone interacts with many, including warfarin,...
📖 Read our full Amiodarone guide →

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 $0.2277 $13.66 / 60 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
65841-0631-05 65841-631-05 Main listing 500 TABLET in 1 BOTTLE 2009-08-10 — Active
65841-0631-06 65841-631-06 30 TABLET in 1 BOTTLE 2009-08-10 — Active
65841-0631-10 65841-631-10 1000 TABLET in 1 BOTTLE 2009-08-10 — Active
65841-0631-14 You're viewing this 60 TABLET in 1 BOTTLE 2009-08-10 — Active
65841-0631-30 65841-631-30 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2009-08-10 — Active
65841-0631-77 65841-631-77 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2009-08-10 — Active

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle.
How does this package differ from NDC 65841-0631-06?
Both are Amiodarone hydrochloride 200 mg Tablet — the drug itself is identical. This page's package is the 60-count one, 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?
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
Amiodarone Hydrochloride 200 mg 00904-6993-61 Major 100 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 00904-7576-61 Major 100 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 29300-0359-05 Unichem 500 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 60687-0437-01 American 100 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 62135-0577-60 Chartwell 60 tablets $0.122 AB Availability likely —
amiodarone hydrochloride 200 mg 68382-0227-05 Zydus 500 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 72888-0039-05 Advagen 500 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 75907-0006-60 Dr. 60 tablets $0.122 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 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 65841-0631-14 Zydus 60 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.

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.

🧪 Avoiding an ingredient? See Amiodarone 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 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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA079029 (ANDA)
Labeler code65841
First marketedAug 2009
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 53 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-840-06 Amiodarone Hydrochloride Tablets USP, 100 mg 30 Tablets Rx only NDC 65841-631-14 in bottle of 60 tablets Amiodarone Hydrochloride Tablets, 200 mg Rx only NDC 65841-841-06 Amiodarone Hydrochloride Tablets USP, 400 mg 30 Tablets Rx only 100 mg label Amiodarone Hydrochloride Tablets, 200 mg 400 mg label

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

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 5 other package presentations of this same product, including 30 tablets (65841-0631-06), 100 tablets (65841-0631-30), 100 tablets (65841-0631-77). 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.
← 65841-0628-01 · Zydus 65841-0633-01 · 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.