ESCITALOPRAM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)

Available from:

Zydus Lifesciences Limited

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [See Clinical Studies (14.1)]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Escitalopram tablets, USP are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [See Clinical Studies (14.2)]. Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent

Product summary:

Escitalopram Tablets, USP equivalent to 5 mg of escitalopram are white to off-white, round, biconvex, film-coated tablets debossed with logo of "ZC", "37" on one side and other side is plain and are supplied as follow: NDC 70771-1145-3 in bottle of 30 tablets NDC 70771-1145-9 in bottle of 90 tablets NDC 70771-1145-1 in bottle of 100 tablets NDC 70771-1145-5 in bottle of 500 tablets NDC 70771-1145-0 in bottle of 1000 tablets Escitalopram Tablets, USP equivalent to 10 mg of escitalopram are white to off-white, round, biconvex, film-coated tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "23" and other side is plain and are supplied as follow: NDC 70771-1146-3 in bottle of 30 tablets NDC 70771-1146-9 in bottle of 90 tablets NDC 70771-1146-1 in bottle of 100 tablets NDC 70771-1146-5 in bottle of 500 tablets NDC 70771-1146-0 in bottle of 1000 tablets Escitalopram Tablets, USP equivalent to 20 mg of escitalopram are white to off-white, round, biconvex, film-coated tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "24" and other side is plain and are supplied as follow: NDC 70771-1147-3 in bottle of 30 tablets NDC 70771-1147-9 in bottle of 90 tablets NDC 70771-1147-1 in bottle of 100 tablets NDC 70771-1147-5 in bottle of 500 tablets NDC 70771-1147-0 in bottle of 1000 tablets Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Manufactured by:
Cadila Healthcare Ltd.
India.
Revised: 11/2022
Document Id: 9516c1f3-9d94-46aa-9516-35f68c184ad8
34391-3
Set id: 76d0e2a8-2ed2-4596-9179-8c360f4a0978
Version: 4
Effective Time: 20221105
Zydus Lifesciences Limited

Summary of Product characteristics

ESCITALOPRAM - ESCITALOPRAM TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
ESCITALOPRAM TABLETS
SPL MEDGUIDE
MANUFACTURED BY:
Cadila Healthcare Ltd.
India.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1145-9 in bottle of 90 tablets
Escitalopram Oxalate Tablets USP, 5 mg
R only
90 tablets
NDC 70771-1146-9 in bottle of 90 tablets
Escitalopram Oxalate Tablets USP, 10 mg
R only
90 tablets
x
x
NDC 70771-1147-9 in bottle of 90 tablets
Escitalopram Oxalate Tablets USP, 20 mg
R only
90 tablets
ESCITALOPRAM
escitalopram tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1145
ROUTE OF ADMINISTRATION
ORAL
x
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM -
UNII:4O4S742ANY)
ESCITALOPRAM
5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z C;37
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1145-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
12/07/2017
2
NDC:70771-
1145-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
12/07/2017
3
NDC:70771-
1145-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
12/07/2017
4
NDC:70771-
1145-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
12/07/2017
5
NDC:70771-
1145-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
12/07/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077734
12/07/2017
ESCITALOPRAM
escitalopram tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
H