Amiodarone Hydrochloride Tablets

SPL v10

SPL

SPL Set ID 3e8db251-e3c5-4fba-be9a-6044a92f0beb

Route

ORAL

Published

Effective Date 2023-01-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Amiodarone (100 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Silicon Dioxide Sodium Starch Glycolate Type A Potato Povidone Starch, Corn Aluminum Oxide D&c Yellow No. 10 Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: 2;98 Shape: round Color: white Color: yellow Size: 8 mm Size: 10 mm Size: 13 mm Score: 2

Marketing Status

ANDA Active Since 2023-02-09

Description

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

Medication Information

Description

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:56.389133 · Updated: 2026-03-14T22:18:11.806691