RAMIPRIL tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Zydus Lifesciences Limited

INN (Internationale Bezeichnung):

RAMIPRIL

Zusammensetzung:

RAMIPRIL 1.25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Ramipril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using ramipril, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that ramipril does not have a similar risk (see WARNINGS). In considering use of ramipril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema). Ramipril tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE

Produktbesonderheiten:

Ramipril Tablets, 1.25 mg are yellow, capsule-shaped, biconvex tablets, debossed with '374' on one side and plain on the other side and are supplied as follows: NDC 65841-699-06 in bottle of 30 tablets NDC 65841-699-16 in bottle of 90 tablets NDC 65841-699-01 in bottle of 100 tablets NDC 65841-699-05 in bottle of 500 tablets NDC 65841-699-10 in bottle of 1000 tablets NDC 65841-699-77 in blister pack of 100 unit dose tablets Ramipril Tablets, 2.5 mg are peach, capsule-shaped, biconvex tablets, debossed with '375' on one side and plain on the other side and are supplied as follows: NDC 65841-700-06 in bottle of 30 tablets NDC 65841-700-16 in bottle of 90 tablets NDC 65841-700-01 in bottle of 100 tablets NDC 65841-700-05 in bottle of 500 tablets NDC 65841-700-10 in bottle of 1000 tablets NDC 65841-700-77 in blister pack of 100 unit dose tablets Ramipril Tablets, 5 mg are pink to red, capsule-shaped, biconvex tablets, debossed with '376' on one side and plain on the other side and are supplied as follows: NDC 65841-701-06 in bottle of 30 tablets NDC 65841-701-16 in bottle of 90 tablets NDC 65841-701-01 in bottle of 100 tablets NDC 65841-701-05 in bottle of 500 tablets NDC 65841-701-10 in bottle of 1000 tablets NDC 65841-701-77 in blister pack of 100 unit dose tablets Ramipril Tablets, 10 mg are white to off-white, capsule-shaped, biconvex tablets, debossed with '377' on one side and plain on the other side and are supplied as follows: NDC 65841-702-06 in bottle of 30 tablets NDC 65841-702-16 in bottle of 90 tablets NDC 65841-702-01 in bottle of 100 tablets NDC 65841-702-05 in bottle of 500 tablets NDC 65841-702-10 in bottle of 1000 tablets NDC 65841-702-77 in blister pack of 100 unit dose tablets 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

RAMIPRIL - RAMIPRIL TABLET
ZYDUS LIFESCIENCES LIMITED
----------
RAMIPRIL TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-699-05 in bottle of 500 tablets
Ramipril Tablets, 1.25 mg
Rx only
500 tablets
NDC 65841-700-05 in bottle of 500 tablets
Ramipril Tablets, 2.5 mg
Rx only
500 tablets
NDC 65841-701-05 in bottle of 500 tablets
Ramipril Tablets, 5 mg
Rx only
500 tablets
NDC 65841-702- 05 in bottle of 500 tablets
Ramipril Tablets, 10 mg
Rx only
500 tablets
RAMIPRIL
ramipril tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-699
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (YELLOW)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
8mm
FLAVOR
IMPRINT CODE
374
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
699-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
2
NDC:65841-
699-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
3
NDC:65841-
699-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
4
NDC:65841-
699-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
5
NDC:65841-
699-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
12/05/2017
6
NDC:65841-
699-77
10 in 1 CARTON
12/05/2017
6
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
ANDA090697
12/05/2017
RAMIPRIL
ramipril tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-700
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY