Ramipril (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 62135-272-01
Ramipril
Capsules, USP
2.5 mg
Rx Only 100 Capsules

PRINCIPAL DISPLAY PANEL
NDC 62135-272-01
Ramipril
Capsules, USP
2.5 mg
Rx Only
100 Capsules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 62135-273-01
Ramipril
Capsules, USP
5 mg
Rx Only 100 Capsules

PRINCIPAL DISPLAY PANEL
NDC 62135-273-01
Ramipril
Capsules, USP
5 mg
Rx Only
100 Capsules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 62135-274-01
Ramipril
Capsules, USP
10 mg
Rx Only 100 Capsules

PRINCIPAL DISPLAY PANEL
NDC 62135-274-01
Ramipril
Capsules, USP
10 mg
Rx Only
100 Capsules
(click image for full-size original)
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-271
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
GELATIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C RED NO. 40
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
FD&C BLUE NO. 2
FD&C BLUE NO. 1
STARCH, CORN
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code CE271;125mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-271-01 100 CAPSULE in 1 BOTTLE None
2 NDC:62135-271-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078745 08/26/2020
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-272
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
GELATIN
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C RED NO. 40
D&C YELLOW NO. 10
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
BUTYL ALCOHOL
FD&C BLUE NO. 2
FD&C BLUE NO. 1
STARCH, CORN
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code CE272;25mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-272-01 100 CAPSULE in 1 BOTTLE None
2 NDC:62135-272-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078745 08/26/2020
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-273
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
GELATIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
D&C RED NO. 28
D&C RED NO. 33
FD&C BLUE NO. 1
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
FD&C BLUE NO. 2
FD&C RED NO. 40
STARCH, CORN
Product Characteristics
Color red Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code CE273;5mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-273-01 100 CAPSULE in 1 BOTTLE None
2 NDC:62135-273-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078745 08/26/2020
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-274
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
GELATIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
D&C RED NO. 28
FD&C BLUE NO. 1
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
FD&C BLUE NO. 2
FD&C RED NO. 40
STARCH, CORN
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code CE274;10mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-274-01 100 CAPSULE in 1 BOTTLE None
2 NDC:62135-274-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078745 08/26/2020
Labeler — Chartwell RX, LLC. (079394054)
Registrant — Chartwell Pharmaceuticals Congers, LLC. (118673447)
Establishment
Name Address ID/FEI Operations
Chartwell Pharmaceuticals Congers, LLC. 118673447 analysis (62135-271), label (62135-271), manufacture (62135-271), pack (62135-271), analysis (62135-272), label (62135-272), manufacture (62135-272), pack (62135-272), analysis (62135-273), label (62135-273), manufacture (62135-273), pack (62135-273), analysis (62135-274), label (62135-274), manufacture (62135-274), pack (62135-274)

Revised: 12/2022 Chartwell RX, LLC.

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