AMIODARONE HYDROCHLORIDE - amiodarone hydrochloride tablet 
Zydus Lifesciences Limited

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AMIODARONE HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-631-14 in bottle of 60 tablets

Amiodarone Hydrochloride Tablets, 200 mg

Rx only

Amiodarone Hydrochloride Tablets, 200 mg
AMIODARONE HYDROCHLORIDE 
amiodarone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-631
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZE;65
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-631-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
2NDC:65841-631-1460 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
3NDC:65841-631-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
4NDC:65841-631-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
5NDC:65841-631-3010 in 1 CARTON08/10/2009
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07902908/10/2009
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-631) , MANUFACTURE(65841-631)

Revised: 8/2022
Document Id: 7c26ff69-c661-48d1-9317-95e2727b74ba
Set id: 3e8db251-e3c5-4fba-be9a-6044a92f0beb
Version: 8
Effective Time: 20220802
 
Zydus Lifesciences Limited