BUSPIRONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)

Available from:

Zydus Lifesciences Limited

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows: Generalized, persistent anxiety (of at least 1 month continual d

Product summary:

Buspirone Hydrochloride Tablets USP, 5 mg are white to off-white, capsule-shaped, flat- faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '36' and other side is plain and are supplied as follows: NDC 65841-781-01 in bottle of 100 tablets NDC 65841-781-05 in bottle of 500 tablets NDC 65841-781-10 in bottle of 1000 tablets NDC 65841-781-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Buspirone Hydrochloride Tablets USP, 10 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '37' and other side is plain and are supplied as follows: NDC 65841-782-01 in bottle of 100 tablets NDC 65841-782-05 in bottle of 500 tablets NDC 65841-782-10 in bottle of 1000 tablets NDC 65841-782-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Buspirone Hydrochloride Tablets USP, 15 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '5' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '38' on other bisect segment and are supplied as follows: NDC 65841-783-14 in bottle of 60 tablets NDC 65841-783-01 in bottle of 100 tablets NDC 65841-783-28 in bottle of 180 tablets NDC 65841-783-05 in bottle of 500 tablets NDC 65841-783-10 in bottle of 1000 tablets NDC 65841-783-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Buspirone Hydrochloride Tablets USP, 30 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '10' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '39' on other bisect segment and are supplied as follows: NDC 65841-784-14 in bottle of 60 tablets NDC 65841-784-10 in bottle of 1000 tablets NDC 65841-784-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage: Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].  Dispense in a tight, light-resistant container. Desyrel® is the registered trademark of Bristol Myers Squibb Company. Synthroid® is the registered trademark of Abbott Laboratories

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cadila Healthcare Limited
----------
Patient Instruction Sheet
Buspirone Hydrochloride Tablets, USP
HOW TO USE
For 15 mg and 30 mg tablets
Response to buspirone varies among individuals. Your physician may
find it necessary to
adjust your dosage to obtain the proper response.
Each tablet is scored and can be broken accurately to provide any of
the following dosages.
To break a tablet accurately and easily, hold the tablet between your
thumbs and index fingers close to the
appropriate tablet score (groove) as shown in the photo. Then, with
the tablet score facing you, apply
pressure and snap the tablet segments apart (segments breaking
incorrectly should not be used).
Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-
1088.
Revised: 1/2020
Document Id: 7c614594-0b5a-4d84-9eaa-2a7ed584be00
34391-3
Set id: 1109dd63-6492-49b1-a383-3ab3a80cd6c7
Version: 4
Effective Time: 20200123
Cadila Healthcare Limited

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE - BUSPIRONE HYDROCHLORIDE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
BUSPIRONE HYDROCHLORIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-781-01 in bottle of 100 tablets
Buspirone Hydrochloride Tablets USP, 5 mg
R only
100 tablets
NDC 65841-842-01 in bottle of 100 tablets
Buspirone Hydrochloride Tablets USP, 7.5 mg
R only
100 tablets
NDC 65841-782-01 in bottle of 100 tablets
x
x
Buspirone Hydrochloride Tablets USP, 10 mg
R only
100 tablets
NDC 65841-783-01 in bottle of 100 tablets
Buspirone Hydrochloride Tablets USP, 15 mg
R only
100 tablets
NDC 65841-784-14 in bottle of 60 tablets
Buspirone Hydrochloride Tablets USP, 30 mg
R only
60 tablets
x
x
x
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-781
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE -
UNII:TK65WKS8HL)
BUSPIRONE
HYDROCHLORIDE
5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
PRODUCT CHARACTERISTICS
COLOR
WHITE (white to off-white)
SCORE
2 pieces
SHAPE
CAPSULE (CAPSULE)
SIZE
8mm
FLAVOR
IMPRINT CODE
Z E;36
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-781-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
05/03/2014
2
NDC:65841-781-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
05/03/2014
3
NDC:65841-781-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
05/03/2014
4
NDC:65841-781-
77
100 in 1 CARTON
05/03/2014
4
NDC:65841-781-
30
1 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
ANDA078888
05/03/2014
B