VENLAFAXINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Available from:

Zydus Lifesciences Limited

INN (International Name):

VENLAFAXINE HYDROCHLORIDE

Composition:

VENLAFAXINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of ven

Product summary:

Venlafaxine Hydrochloride Tablets equivalent to 25 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of  "ZC" and other side is debossed with "64" and other side is plain and are supplied as follows: NDC 65841-671-06 in bottles of 30 tablets NDC 65841-671-14 in bottles of 60 tablets NDC 65841-671-16 in bottles of 90 tablets NDC 65841-671-01 in bottles of 100 tablets NDC 65841-671-05 in bottles of 500 tablets NDC 65841-671-10 in bottles of 1000 tablets Venlafaxine Hydrochloride Tablets equivalent to 37.5 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of bisect is debossed with logo of "ZC" and other side is debossed with "65" and other side is plain and are supplied as follows: NDC 65841-672-06 in bottles of 30 tablets NDC 65841-672-14 in bottles of 60 tablets NDC 65841-672-16 in bottles of 90 tablets NDC 65841-672-01 in bottles of 100 tablets NDC 65841-672-05 in bottles of 500 tablets NDC 65841-672-10 in bottles of 1000 tablets Venlafaxine Hydrochloride Tablets equivalent to 50 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "66"  and other side is plain and are supplied as follows: NDC 65841-673-06 in bottles of 30 tablets NDC 65841-673-14 in bottles of 60 tablets NDC 65841-673-16 in bottles of 90 tablets NDC 65841-673-01 in bottles of 100 tablets NDC 65841-673-05 in bottles of 500 tablets NDC 65841-673-10 in bottles of 1000 tablets Venlafaxine Hydrochloride Tablets equivalent to 75 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side;  one side of the bisect is debossed with logo of "ZC" and other side is debossed with "67" and other side is plain and are supplied as follows: NDC 65841-674-06 in bottles of 30 tablets NDC 65841-674-14 in bottles of 60 tablets NDC 65841-674-16 in bottles of 90 tablets NDC 65841-674-01 in bottles of 100 tablets NDC 65841-674-05 in bottles of 500 tablets NDC 65841-674-10 in bottles of 1000 tablets Venlafaxine Hydrochloride Tablets equivalent to 100 mg of venlafaxine are peach-colored, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of  "ZC"  and other side is debossed with "68" and other side is plain and are supplied as follows: NDC 65841-675-06 in bottles of 30 tablets NDC 65841-675-14 in bottles of 60 tablets NDC 65841-675-16 in bottles of 90 tablets NDC 65841-675-01 in bottles of 100 tablets NDC 65841-675-05 in bottles of 500 tablets NDC 65841-675-10 in bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP. KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Revised: 9/2023
Document Id: 637bdb70-ec58-4ef7-9bf3-b9977f4f0ccc
34391-3
Set id: 51334651-7a7f-4653-bf9d-d5be04fd902d
Version: 9
Effective Time: 20230928
Zydus Lifesciences Limited

Summary of Product characteristics

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE TABLET
ZYDUS LIFESCIENCES LIMITED
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VENLAFAXINE HYDROCHLORIDE TABLETS
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-671-01 in bottle of 100 Tablets
Venlafaxine Hydrochloride Tablets, 25 mg
Rx only
100 TABLETS
NDC 65841-672-01 in bottle of 100 Tablets
Venlafaxine Hydrochloride Tablets, 37.5 mg
Rx only
100 TABLETS
NDC 65841-673-01 in bottle of 100 Tablets
Venlafaxine Hydrochloride Tablets, 50 mg
Rx only
100 TABLETS
NDC 65841-674-01 in bottle of 100 Tablets
Venlafaxine Hydrochloride Tablets, 75 mg
Rx only
100 TABLETS
NDC 65841-675-01 in bottle of 100 Tablets
Venlafaxine Hydrochloride Tablets, 100 mg
Rx only
100 TABLETS
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-671
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE -
UNII:GRZ 5RCB1QG)
VENLAFAXINE
25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
ORANGE (PEACH)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z C;64
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-671-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
06/13/2008
2
NDC:65841-671-
14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
06/13/2008
3
NDC:65841-671-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
06/13/2008
4
NDC:65841-671-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
06/13/2008
5
NDC:65841-671-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
06/13/2008
6
NDC:65841-671-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
06/13/2008