ATENOLOL - atenolol tablet 
Zydus Lifesciences Limited

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Atenolol Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-022-01 in bottles of 100 tablets

Atenolol Tablets USP, 25 mg

Rx only

100 Tablets

Atenolol Tablets, 25 mg

NDC 65841-023-01 in bottles of 100 tablets

Atenolol Tablets USP, 50 mg

Rx only

100 Tablets

Atenolol Tablets, 50 mg

NDC 65841-024-01 in bottles of 100 tablets

Atenolol Tablets USP, 100 mg

Rx only

100 Tablets

Atenolol Tablets, 100 mg
ATENOLOL 
atenolol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF- WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code Z;65
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-022-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
2NDC:65841-022-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
3NDC:65841-022-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
4NDC:65841-022-405000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
5NDC:65841-022-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07690010/08/2005
ATENOLOL 
atenolol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code Z;66
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-023-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
2NDC:65841-023-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
3NDC:65841-023-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
4NDC:65841-023-022000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
5NDC:65841-023-405000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
6NDC:65841-023-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07690010/08/2005
ATENOLOL 
atenolol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-024
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE (UNII: FZ989GH94E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF- WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code Z;67
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-024-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
2NDC:65841-024-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
3NDC:65841-024-405000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
4NDC:65841-024-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07690010/08/2005
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)

Revised: 8/2022
Document Id: dcaaa30b-389f-4409-8c25-8e1b9a1e76cc
Set id: 2492d5f6-00b0-42c9-a793-2be83ea81ad1
Version: 9
Effective Time: 20220803
 
Zydus Lifesciences Limited