RAMIPRIL- ramipril capsule 
Cadila Healthcare Limited

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RAMIPRIL CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-655-06 in bottle of 30 Capsules

Ramipril Capsules, 1.25 mg

Rx only

30 Capsules

Ramipril Capsules, 1.25 mg

NDC 65841-656-01 in bottle of 100 Capsules

Ramipril Capsules, 2.5 mg

Rx only

100 Capsules

Ramipril Capsules, 2.5 mg

NDC 65841-657-01 in bottle of 100 Capsules

Ramipril Capsules, 5 mg

Rx only

100 Capsules

Ramipril Capsules, 5 mg

NDC 65841-658-01 in bottle of 100 Capsules

Ramipril Capsules, 10 mg

Rx only

100 Capsules

Ramipril Capsules, 10 mg
RAMIPRIL 
ramipril capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-655
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL1.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorWHITE (WHITE) , YELLOW (YELLOW) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code ZA;43;1;25mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-655-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
2NDC:65841-655-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
3NDC:65841-655-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
4NDC:65841-655-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
5NDC:65841-655-3010 in 1 CARTON11/20/2010
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07883211/20/2010
RAMIPRIL 
ramipril capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-656
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL2.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorWHITE (WHITE) , ORANGE (ORANGE) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code ZA;44;2;5mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-656-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
2NDC:65841-656-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
3NDC:65841-656-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
4NDC:65841-656-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
5NDC:65841-656-3010 in 1 CARTON11/20/2010
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07883211/20/2010
RAMIPRIL 
ramipril capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-657
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorWHITE (WHITE) , RED (RED) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code ZA;45;5mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-657-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
2NDC:65841-657-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
3NDC:65841-657-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
4NDC:65841-657-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
5NDC:65841-657-3010 in 1 CARTON11/20/2010
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07883211/20/2010
RAMIPRIL 
ramipril capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-658
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL10 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorWHITE (WHITE) , BLUE (BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code ZA;46;10mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-658-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
2NDC:65841-658-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
3NDC:65841-658-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
4NDC:65841-658-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
5NDC:65841-658-3010 in 1 CARTON11/20/2010
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07883211/20/2010
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-655, 65841-656, 65841-657, 65841-658) , MANUFACTURE(65841-655, 65841-656, 65841-657, 65841-658)

Revised: 9/2020
Document Id: 5c6923e7-888e-4ea4-a32b-7f0dffe52231
Set id: 496b346b-ca79-4483-a950-bed9464e6a9d
Version: 5
Effective Time: 20200914
 
Cadila Healthcare Limited