Ramipril

RAMIPRIL- ramipril capsule
Cadila Healthcare Limited

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
(click image for full-size original)

NDC 65841-656-01 in bottle of 100 Capsules

Ramipril Capsules, 2.5 mg

Rx only

100 Capsules

Ramipril Capsules, 2.5 mg
(click image for full-size original)

NDC 65841-657-01 in bottle of 100 Capsules

Ramipril Capsules, 5 mg

Rx only

100 Capsules

Ramipril Capsules, 5 mg
(click image for full-size original)

NDC 65841-658-01 in bottle of 100 Capsules

Ramipril Capsules, 10 mg

Rx only

100 Capsules

Ramipril Capsules, 10 mg
(click image for full-size original)
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-655
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 1.25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
GELATIN
TITANIUM DIOXIDE
STARCH, CORN
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (WHITE) , YELLOW (YELLOW) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code ZA;43;1;25mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-655-06 30 CAPSULE in 1 BOTTLE None
2 NDC:65841-655-16 90 CAPSULE in 1 BOTTLE None
3 NDC:65841-655-01 100 CAPSULE in 1 BOTTLE None
4 NDC:65841-655-05 500 CAPSULE in 1 BOTTLE None
5 NDC:65841-655-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-655-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078832 11/20/2010
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-656
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 2.5 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C RED NO. 40
GELATIN
TITANIUM DIOXIDE
STARCH, CORN
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (WHITE) , ORANGE (ORANGE) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code ZA;44;2;5mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-656-06 30 CAPSULE in 1 BOTTLE None
2 NDC:65841-656-16 90 CAPSULE in 1 BOTTLE None
3 NDC:65841-656-01 100 CAPSULE in 1 BOTTLE None
4 NDC:65841-656-05 500 CAPSULE in 1 BOTTLE None
5 NDC:65841-656-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-656-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078832 11/20/2010
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-657
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
TITANIUM DIOXIDE
STARCH, CORN
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (WHITE) , RED (RED) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code ZA;45;5mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-657-06 30 CAPSULE in 1 BOTTLE None
2 NDC:65841-657-16 90 CAPSULE in 1 BOTTLE None
3 NDC:65841-657-01 100 CAPSULE in 1 BOTTLE None
4 NDC:65841-657-05 500 CAPSULE in 1 BOTTLE None
5 NDC:65841-657-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-657-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078832 11/20/2010
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAMIPRIL (RAMIPRILAT) RAMIPRIL 10 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
TITANIUM DIOXIDE
STARCH, CORN
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (WHITE) , BLUE (BLUE) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code ZA;46;10mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-658-06 30 CAPSULE in 1 BOTTLE None
2 NDC:65841-658-16 90 CAPSULE in 1 BOTTLE None
3 NDC:65841-658-01 100 CAPSULE in 1 BOTTLE None
4 NDC:65841-658-05 500 CAPSULE in 1 BOTTLE None
5 NDC:65841-658-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-658-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078832 11/20/2010
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-655), ANALYSIS (65841-656), ANALYSIS (65841-657), ANALYSIS (65841-658), MANUFACTURE (65841-655), MANUFACTURE (65841-656), MANUFACTURE (65841-657), MANUFACTURE (65841-658)

Revised: 09/2020 Cadila Healthcare Limited

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