Ramipril (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ramipril Capsules USP, 1.25 mg are yellow/yellow size ‘4’ hard gelatin capsules imprinted with ‘D’ on yellow cap and ‘05’ on yellow body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-428-00


Ramipril Capsules USP, 2.5 mg are orange/orange size ‘4’ hard gelatin capsules imprinted with ‘D’ on orange cap and ‘06’ on orange body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-429-00
Ramipril Capsules USP, 5 mg are red/red size ‘4’ hard gelatin capsules imprinted with ‘D’ on red cap and ‘07’ on red body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-430-00
Bottles of 500 NDC 68001-430-03
Ramipril Capsules USP, 10 mg are blue/blue size ‘4’ hard gelatin capsules imprinted with ‘D’ on blue cap and ‘08’ on blue body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-431-00
Bottles of 500 NDC 68001-431-03

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Dispense in well-closed container with safety closure.

17 PATIENT COUNSELING INFORMATION

Angioedema

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician.

Neutropenia

Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.

Symptomatic Hypotension

Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ramipril if syncope (fainting) occurs, and to follow up with their health care providers.

Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ramipril can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to ramipril during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.

Hyperkalemia

Advise patients not to use salt substitutes containing potassium without consulting their physician.

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

For BluePoint Laboratories
M.L No.: 19/ HD/ AP/ 95/ F/ R

Revised: 08/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1.25 mg (100 Capsule Bottle)

NDC 68001-428-00
Rx only
Ramipril Capsules, USP
1.25 mg BluePoint Laboratories 100 Capsules

Ramipril Capsules 1.25mg 100 Capsules Rev 01/2020
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (100 Capsule Bottle)

NDC 68001-429-00
Rx only
Ramipril Capsules, USP
2.5 mg BluePoint Laboratories 100 Capsules

Ramipril Capsules USP 2.5mg 100 Capsules Rev 01/2020
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Capsule Bottle)

NDC 68001-430-00
Rx only
Ramipril Capsules, USP
5 mg BluePoint Laboratories 100 Capsules

Ramipril Capsules USP 5mg 100 Capsules Rev 01/2020
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Capsule Bottle)

NDC 68001-431-00
Rx only
Ramipril Capsules, USP
10 mg BluePoint Laboratories 100 Capsules

Ramipril Capsules USP 10mg 100 Capsules Rev 01/2020
(click image for full-size original)
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-428
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
STARCH, CORN
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code D;05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-428-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091604 02/28/2020
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-429
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
STARCH, CORN
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
D&C YELLOW NO. 10
FD&C RED NO. 40
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code D;06
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-429-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091604 02/28/2020
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-430
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
STARCH, CORN
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
FD&C BLUE NO. 1
FD&C RED NO. 40
Product Characteristics
Color red Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code D;07
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-430-00 100 CAPSULE in 1 BOTTLE None
2 NDC:68001-430-03 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091604 02/28/2020
RAMIPRIL ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-431
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
STARCH, CORN
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
FD&C BLUE NO. 1
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code D;08
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-431-00 100 CAPSULE in 1 BOTTLE None
2 NDC:68001-431-03 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091604 02/28/2020
Labeler — BluePoint Laboratories (985523874)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 analysis (68001-428), analysis (68001-429), analysis (68001-430), analysis (68001-431), manufacture (68001-428), manufacture (68001-429), manufacture (68001-430), manufacture (68001-431)

Revised: 09/2021 BluePoint Laboratories

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.