NITROGLYCERIN- nitroglycerin tablet 
Zydus Lifesciences Limited

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Nitroglycerin Sublingual Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1717-1

Nitroglycerin Sublingual Tablets, USP 0.3 mg

Rx only

100 Tablets

0.3 mg label

NDC 70771-1718-1

Nitroglycerin Sublingual Tablets 0.4 mg

Rx only

100 Tablets

0.4 mg label

NDC 70771-1719-1

Nitroglycerin Sublingual Tablets 0.6 mg

Rx only

100 Tablets

0.6 mg label
NITROGLYCERIN 
nitroglycerin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1717
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN0.3 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF WHITE) Scoreno score
ShapeROUNDSize4mm
FlavorImprint Code 3;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1717-11 in 1 CARTON02/02/202303/25/2025
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21015302/02/202304/29/2025
NITROGLYCERIN 
nitroglycerin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1718
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN0.4 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF WHITE) Scoreno score
ShapeROUNDSize4mm
FlavorImprint Code 4;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1718-11 in 1 CARTON02/02/202303/25/2025
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70771-1718-44 in 1 CARTON02/02/202303/25/2025
225 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21015302/02/202304/29/2025
NITROGLYCERIN 
nitroglycerin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1719
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN0.6 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (OFF WHITE) Scoreno score
ShapeROUNDSize4mm
FlavorImprint Code 6;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1719-11 in 1 CARTON02/02/202303/25/2025
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21015302/02/202304/29/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1717, 70771-1718, 70771-1719) , MANUFACTURE(70771-1717, 70771-1718, 70771-1719)

Revised: 4/2025
Document Id: 0f4d80a8-afae-4a80-bb8f-8362c57bef62
Set id: bf6b64a2-d166-4be0-8972-51f56e30f92a
Version: 4
Effective Time: 20250429
 
Zydus Lifesciences Limited