NADOLOL - nadolol tablet 
Zydus Lifesciences Limited

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Nadolol Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1089-9

Nadolol tablets, 20 mg

Rx only

90 tablets

Nadolol tablets

NDC 70771-1090-9

Nadolol tablets, 40 mg

Rx only

90 tablets

Nadolol tablets

NDC 70771-1091-9

Nadolol tablets, 80 mg

Rx only

80 tablets

Nadolol tablets
NADOLOL 
nadolol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1090
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V) NADOLOL40 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code N;40
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1090-410 in 1 CARTON08/08/2017
1NDC:70771-1090-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1090-990 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
3NDC:70771-1090-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
4NDC:70771-1090-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776108/08/2017
NADOLOL 
nadolol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1091
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V) NADOLOL80 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (BLUE) Score2 pieces
ShapeROUND (ROUND) Size11mm
FlavorImprint Code N;80
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1091-990 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
2NDC:70771-1091-410 in 1 CARTON08/08/2017
2NDC:70771-1091-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:70771-1091-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
4NDC:70771-1091-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776108/08/2017
NADOLOL 
nadolol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1089
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V) NADOLOL20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code N;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1089-990 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
2NDC:70771-1089-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
3NDC:70771-1089-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
4NDC:70771-1089-410 in 1 CARTON08/08/2017
4NDC:70771-1089-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776108/08/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1089, 70771-1090, 70771-1091) , MANUFACTURE(70771-1089, 70771-1090, 70771-1091)

Revised: 10/2022
Document Id: 12724794-e065-43e8-87ab-bf23f52ae01d
Set id: 29433c5a-51c6-4fb9-9174-1b1c616c9e57
Version: 4
Effective Time: 20221031
 
Zydus Lifesciences Limited