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

100 mg label

NDC 65841-631-14 in bottle of 60 tablets

Amiodarone Hydrochloride Tablets, 200 mg

Rx only

Amiodarone Hydrochloride Tablets, 200 mg

NDC 65841-841-06

Amiodarone Hydrochloride Tablets USP, 400 mg

30 Tablets

Rx only

400 mg label
AMIODARONE HYDROCHLORIDE 
amiodarone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-840
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE100 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 (OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 297
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-840-0630 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07902902/09/2023
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:65841-631-7710 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
AMIODARONE HYDROCHLORIDE 
amiodarone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-841
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE400 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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorYELLOW (PALE YELLOW TO YELLOW) Score2 pieces
ShapeROUND (ROUND) Size13mm
FlavorImprint Code 2;98
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-841-0630 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07902902/09/2023
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-631, 65841-840, 65841-841) , MANUFACTURE(65841-631, 65841-840, 65841-841)

Revised: 11/2024
Document Id: aabb5533-5d41-49a3-b8b6-14627af57311
Set id: 3e8db251-e3c5-4fba-be9a-6044a92f0beb
Version: 10
Effective Time: 20241125
 
Zydus Lifesciences Limited