RAMIPRIL - ramipril tablet 
Zydus Lifesciences Limited

----------

Ramipril Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-699-05 in bottle of 500 tablets

Ramipril Tablets, 1.25 mg

Rx only

500 tablets

Ramipril Tablets, 1.25 mg

NDC 65841-700-05 in bottle of 500 tablets

Ramipril Tablets, 2.5 mg

Rx only

500 tablets

Ramipril Tablets, 2.5 mg

NDC 65841-701-05 in bottle of 500 tablets

Ramipril Tablets, 5 mg

Rx only

500 tablets

Ramipril Tablets, 5 mg

NDC 65841-702- 05 in bottle of 500 tablets

Ramipril Tablets, 10 mg

Rx only

500 tablets

Ramipril Tablets, 10 mg
RAMIPRIL 
ramipril tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-699
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL1.25 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeCAPSULE (CAPSULE) Size8mm
FlavorImprint Code 374
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-699-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:65841-699-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:65841-699-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:65841-699-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
5NDC:65841-699-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
6NDC:65841-699-7710 in 1 CARTON12/05/2017
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09069712/05/2017
RAMIPRIL 
ramipril tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL2.5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeCAPSULE (CAPSULE) Size8mm
FlavorImprint Code 375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-700-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:65841-700-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:65841-700-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:65841-700-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
5NDC:65841-700-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
6NDC:65841-700-7710 in 1 CARTON12/05/2017
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09069712/05/2017
RAMIPRIL 
ramipril tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-701
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorRED (PINK TO RED) Scoreno score
ShapeCAPSULE (CAPSULE) Size8mm
FlavorImprint Code 376
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-701-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:65841-701-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:65841-701-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:65841-701-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
5NDC:65841-701-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
6NDC:65841-701-7710 in 1 CARTON12/05/2017
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09069712/05/2017
RAMIPRIL 
ramipril tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-702
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size8mm
FlavorImprint Code 377
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-702-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:65841-702-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:65841-702-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:65841-702-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
5NDC:65841-702-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
6NDC:65841-702-7710 in 1 CARTON12/05/2017
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09069712/05/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-699, 65841-700, 65841-701, 65841-702) , MANUFACTURE(65841-699, 65841-700, 65841-701, 65841-702)

Revised: 10/2022
Document Id: 3c272717-5c87-4f26-ad63-6034e5c40b41
Set id: 3c358a20-9abb-4fc0-afb9-400e3c621fe2
Version: 5
Effective Time: 20221014
 
Zydus Lifesciences Limited