Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Amiodarone Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Chartwell RX, LLC

DUNS: 079394054

Effective Date

August 23, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Amiodarone(100 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Amiodarone Hydrochloride

Product Details

NDC Product Code

62135-576

Application Number

ANDA077069

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 23, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

AmiodaroneActive

Code: 976728SY6ZClass: ACTIBQuantity: 100 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Amiodarone Hydrochloride

Product Details

NDC Product Code

62135-577

Application Number

ANDA077069

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 23, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

AmiodaroneActive

Code: 976728SY6ZClass: ACTIBQuantity: 200 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Amiodarone Hydrochloride

Product Details

NDC Product Code

62135-578

Application Number

ANDA077069

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 23, 2023

Ingredients

AmiodaroneActive

Code: 976728SY6ZClass: ACTIBQuantity: 400 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy