RAMIPRIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)

Available from:

Zydus Lifesciences Limited

INN (International Name):

RAMIPRIL

Composition:

RAMIPRIL 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ramipril capsules, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with diffe

Product summary:

Ramipril Capsules, 1.25 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-43" in black ink and yellow opaque body printed with "1.25 mg" in black ink and are supplied as follows: NDC 65841-655-06 in bottle of 30 capsules NDC 65841-655-16 in bottle of 90 capsules NDC 65841-655-01 in bottle of 100 capsules NDC 65841-655-05 in bottle of 500 capsules NDC 65841-655-30 in blister of 100 capsules Ramipril Capsules, 2.5 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-44" in black ink and orange opaque body printed with "2.5 mg" in black ink and are supplied as follows: NDC 65841-656-06 in bottle of 30 capsules NDC 65841-656-16 in bottle of 90 capsules NDC 65841-656-01 in bottle of 100 capsules NDC 65841-656-05 in bottle of 500 capsules NDC 65841-656-30 in blister of 100 capsules Ramipril Capsules, 5 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-45" in black ink and red opaque body printed with "5 mg" in black ink and are supplied as follows: NDC 65841-657-06 in bottle of 30 capsules NDC 65841-657-16 in bottle of 90 capsules NDC 65841-657-01 in bottle of 100 capsules NDC 65841-657-05 in bottle of 500 capsules NDC 65841-657-30 in blister of 100 capsules Ramipril Capsules, 10 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-46" in black ink and blue opaque body printed with "10 mg" in black ink and are supplied as follows: NDC 65841-658-06 in bottle of 30 capsules NDC 65841-658-16 in bottle of 90 capsules NDC 65841-658-01 in bottle of 100 capsules NDC 65841-658-05 in bottle of 500 capsules NDC 65841-658-30 in blister of 100 capsules Storage:    Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL - RAMIPRIL CAPSULE
ZYDUS LIFESCIENCES LIMITED
----------
RAMIPRIL CAPSULES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-655-06 in bottle of 30 Capsules
Ramipril Capsules, 1.25 mg
R only
30 Capsules
NDC 65841-656-01 in bottle of 100 Capsules
Ramipril Capsules, 2.5 mg
R only
100 Capsules
x
x
NDC 65841-657-01 in bottle of 100 Capsules
Ramipril Capsules, 5 mg
R only
100 Capsules
NDC 65841-658-01 in bottle of 100 Capsules
Ramipril Capsules, 10 mg
R only
x
x
100 Capsules
RAMIPRIL
ramipril capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-655
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
RAMIPRIL
1.25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
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
COLOR
WHITE (WHITE) , YELLOW (YELLOW)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
14mm
FLAVOR
IMPRINT CODE
Z A;43;1;25mg
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
655-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
11/20/2010
2
NDC:65841-
655-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
11/20/2010
3
NDC:65841-
655-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/20/2010
4
NDC:65841-
655-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/20/2010
5
NDC:65841-
655-30
10 in 1 CARTON
11/20/2010
5
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
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
ACTIVE INGREDIENT/ACT