AMIODARONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)

Available from:

Zydus Lifesciences Limited

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - Cardiogenic shock. - Sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - Known hypersensitivity to the drug or to any of its components, including iodine. Risk Summary Available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. Untreated underl

Product summary:

Amiodarone Hydrochloride Tablets USP, 200 mg are white to off-white, round-shaped, flat beveled-edge, uncoated tablets with bisect on one side and other side is plain; one side of bisect is debossed with 'ZE' and other side is debossed with '65' and are supplied as follows: NDC 65841-631-06 in bottle of 30 tablets NDC 65841-631-14 in bottle of 60 tablets NDC 65841-631-05 in bottle of 500 tablets NDC 65841-631-10 in bottle of 1000 tablets NDC 65841-631-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
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Revised: 1/2023
Document Id: 9efa81cc-3f65-4cb9-8fe0-cafbb1bf7fb6
34391-3
Set id: 3e8db251-e3c5-4fba-be9a-6044a92f0beb
Version: 9
Effective Time: 20230127
Zydus Lifesciences Limited

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE - AMIODARONE HYDROCHLORIDE TABLET
ZYDUS LIFESCIENCES LIMITED
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AMIODARONE HYDROCHLORIDE TABLETS
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
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-840
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE -
UNII:N3RQ532IUT)
AMIODARONE
HYDROCHLORIDE
100 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
WHITE (OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
8mm
FLAVOR
IMPRINT CODE
297
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-840-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
02/09/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA079029
02/09/2023
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-631
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE -
UNII:N3RQ532IUT)
AMIODARONE
HYDROCHLORIDE
200 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNI