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Amiodarone hydrochloride - Medication Information

Product NDC Code 65841-631
Drug Name

Amiodarone hydrochloride

Type Generic
Pharm Class Antiarrhythmic [EPC],
Cytochrome P450 1A2 Inhibitors [MoA],
Cytochrome P450 2C9 Inhibitors [MoA],
Cytochrome P450 2D6 Inhibitors [MoA],
Cytochrome P450 3A4 Inhibitors [MoA],
P-Glycoprotein Inhibitors [MoA]
Active Ingredients
Amiodarone hydrochloride 200 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 833528,
834348,
835956
Application Number ANDA079029
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
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
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Spl product data elements

Usually a list of ingredients in a drug product.
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

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API