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FDA Drug information

Amiodarone hydrochloride

Read time: 1 mins
Marketing start date: 25 Mar 2025
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Summary of product characteristics


Effective Time

20241125

Version

10

Spl Product Data Elements

Amiodarone hydrochloride Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE AMIODARONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE STARCH, CORN OFF-WHITE ROUND 297 Amiodarone hydrochloride Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE AMIODARONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE STARCH, CORN WHITE TO OFF-WHITE ROUND ZE;65 Amiodarone hydrochloride Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE AMIODARONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO ALUMINUM OXIDE STARCH, CORN POVIDONE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW PALE YELLOW TO YELLOW ROUND 2;98

Application Number

ANDA079029

Brand Name

Amiodarone hydrochloride

Generic Name

Amiodarone hydrochloride

Product Ndc

65841-840

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

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 100 mg label Amiodarone Hydrochloride Tablets, 200 mg 400 mg label

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