DIVALPROEX SODIUM tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Available from:

Zydus Lifesciences Limited

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium extended-release tablets, USP are valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets  is based in part on studies of divalproex sodium delayed release tablets in this indication, and was confirmed in a 3 week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studi

Product summary:

Divalproex Sodium Extended-release Tablets USP, 250 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA47" on one side and the other side plain and are supplied as follows: NDC 65841-637-14 in bottle of 60 tablets NDC 65841-637-16 in bottle of 90 tablets NDC 65841-637-01 in bottle of 100 tablets NDC 65841-637-133-05 in bottle of 500 tablets Divalproex Sodium Extended-release Tablets  USP, 500 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA48" on one side and the other side plain and are supplied as follows: NDC 65841-638-16 in bottle of 90 tablets NDC 65841-638-01 in bottle of 100 tablets NDC 65841-638-05 in bottle of 500 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Maalox® is the registered trademark of Novartis Consumer Health. Trisogel® is the registered trademark of Eli Lilly Corporation. Titralac® is the registered trademark of 3M Pharmaceuticals.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Manufactured by:
Cadila Healthcare Ltd.
India.
Revised: 10/2022
Document Id: d0431c44-92e9-4479-b41f-809ec0b171bf
34391-3
Set id: 4f40e035-fdad-42c9-bd31-c1582215f83e
Version: 6
Effective Time: 20221013
Zydus Lifesciences Limited

Summary of Product characteristics

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS
SPL MEDGUIDE
MANUFACTURED BY:
Cadila Healthcare Ltd.
India.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-637-01 in bottle of 100 tablets
Divalproex Sodium ER Tablets, 250 mg
Rx only
100 tablets
NDC 65841-638-01 in bottle of 100 tablets
Divalproex Sodium ER Tablets, 500 mg
Rx only
100 tablets
DIVALPROEX SODIUM
divalproex sodium tablet, film coated, extended release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-637
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
VALPROIC ACID
250 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
18mm
FLAVOR
IMPRINT CODE
Z A47
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-637-
14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
01/07/2013
2
NDC:65841-637-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
01/07/2013
3
NDC:65841-637-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
01/07/2013
4
NDC:65841-637-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
01/07/2013
MARKETING INFORMATION
MARKETING
CATEGORY
APPLIC