PROPRANOLOL HYDROCHLORIDE capsule, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Tillgänglig från:

Zydus Lifesciences Limited

INN (International namn):

PROPRANOLOL HYDROCHLORIDE

Sammansättning:

PROPRANOLOL HYDROCHLORIDE 60 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Propranolol hydrochloride extended-release capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3)

Produktsammanfattning:

Propranolol Hydrochloride Extended-release Capsules USP, 60 mg are white to off-white, free flowing pellets filled in size '3' hard gelatin capsules with white colored cap printed with  "ZA-57" in black ink and light blue body printed with "60 mg" in black ink and are supplied as follows: NDC 65841-745-16 in bottle of 90 capsules NDC 65841-745-01 in bottle of 100 capsules NDC 65841-745-05 in bottle of 500 capsules NDC 65841-745-10 in bottle of 1000 capsules NDC 65841-745-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules   Propranolol Hydrochloride Extended-release Capsules USP, 80 mg are white to off-white, free flowing pellets filled in size '3' hard gelatin capsules with light blue colored cap printed with "ZA-58" in black ink and light blue body printed with "80 mg" in black ink and are supplied as follows: NDC 65841-746-16 in bottle of 90 capsules NDC 65841-746-01 in bottle of 100 capsules NDC 65841-746-05 in bottle of 500 capsules NDC 65841-746-10 in bottle of 1000 capsules NDC 65841-746-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules   Propranolol Hydrochloride Extended-release Capsules USP, 120 mg are white to off- white, free flowing pellets filled in size'2' hard gelatin capsules with dark blue colored cap printed with "ZA-59" in black ink and light blue body printed with "120 mg" in black ink and are supplied as follows: NDC 65841-747-16 in bottle of 90 capsules NDC 65841-747-01 in bottle of 100 capsules NDC 65841-747-05 in bottle of 500 capsules NDC 65841-747-10 in bottle of 1000 capsules NDC 65841-747-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules   Propranolol Hydrochloride Extended-release Capsules USP, 160 mg are white to off- white, free flowing pellets filled in size '1' hard gelatin capsules with dark blue colored cap printed with "ZA-60" in black ink and dark blue body printed with "160 mg" in black ink and are supplied as follows: NDC 65841-748-16 in bottle of 90 capsules NDC 65841-748-01 in bottle of 100 capsules NDC 65841-748-05 in bottle of 500 capsules NDC 65841-748-10 in bottle of 1000 capsules NDC 65841-748-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PROPRANOLOL HYDROCHLORIDE - PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-745-01 in bottle of 100 Capsules
Propranolol Hydrochloride Extended-release Capsules USP, 60 mg
Rx only
100 CAPSULES
NDC 65841-746-01 in bottle of 100 Capsules
Propranolol Hydrochloride Extended-release Capsules USP, 80 mg
Rx only
100 CAPSULES
NDC 65841-747-01 in bottle of 100 Capsules
Propranolol Hydrochloride Extended-release Capsules USP, 120 mg
Rx only
100 CAPSULES
NDC 65841-748-01 in bottle of 100 Capsules
Propranolol Hydrochloride Extended-release Capsules USP, 160 mg
Rx only
100 CAPSULES
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride capsule, extended release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-745
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL -
UNII:9Y8NXQ24VQ)
PROPRANOLOL
HYDROCHLORIDE
60 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
D&C RED NO. 28 (UNII: 767IP0Y5NH)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE) , BLUE (LIGHT BLUE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
16mm
FLAVOR
IMPRINT CODE
Z A;57;60;mg
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-745-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
04/15/2014
2
NDC:65841-745-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
04/15/2014
3
NDC:65841-745-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
04/15/2014
4
NDC:65841-745-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
04/15/2014
5
NDC:65841-745-
77
100 in 1 CARTON
04/15/2014