amiodarone hydrochloride (65841-631)

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride

Generic Name amiodarone hydrochloride

Labeler zydus lifesciences limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer

Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-631

Product ID 65841-631_aabb5533-5d41-49a3-b8b6-14627af57311

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA079029

Listing Expiration 2026-12-31

Marketing Start 2009-08-10

Pharmacologic Class

Classes

antiarrhythmic [epc] cytochrome p450 1a2 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841631

Hyphenated Format 65841-631

Supplemental Identifiers

RxCUI

833528 834348 835956

UNII

976728SY6Z

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amiodarone hydrochloride (source: ndc)

Generic Name amiodarone hydrochloride (source: ndc)

Application Number ANDA079029 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE (65841-631-05)
30 TABLET in 1 BOTTLE (65841-631-06)
1000 TABLET in 1 BOTTLE (65841-631-10)
60 TABLET in 1 BOTTLE (65841-631-14)
10 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK

source: ndc

Packages (5)

65841-631-05 500 TABLET in 1 BOTTLE (65841-631-05) 65841-631-06 30 TABLET in 1 BOTTLE (65841-631-06) 65841-631-10 1000 TABLET in 1 BOTTLE (65841-631-10) 65841-631-14 60 TABLET in 1 BOTTLE (65841-631-14) 65841-631-77 10 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

amiodarone hydrochloride (200 mg/1)

Linked Drug Pages (1)

Amiodarone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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