DIVALPROEX SODIUM tablet, delayed release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Zydus Lifesciences Limited

INN (Rahvusvaheline Nimetus):

DIVALPROEX SODIUM

Koostis:

VALPROIC ACID 125 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. 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. The efficacy of divalproex sodium was established in 3 week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)] . The safety and effectiveness of divalproex sodium for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Divalproex sodium delayed-release tablets are indicated as monothe

Toote kokkuvõte:

Divalproex Sodium Delayed-release Tablets, USP equivalent to 125 mg of valproic acid, are white to off-white having mottled spots, oval shaped, enteric-coated tablets with the logo of "ZA08" on one side and plain on other side and are supplied as follows: NDC 65841-634-01 in bottles of 100 tablets NDC 65841-634-05 in bottles of 500 tablets Divalproex Sodium Delayed-release Tablets, USP equivalent to 250 mg of valproic acid, are white to off-white having mottled spots, oval shape, convex, enteric-coated tablets imprinted with the logo of "ZA07" on one side and plain on other side and are supplied as follows: NDC 65841-635-01 in bottles of 100 tablets NDC 65841-635-05 in bottles of 500 tablets Divalproex Sodium Delayed-release Tablets, USP equivalent to 500 mg of valproic acid, are white to off-white having mottled spots, oval shape, beveled edge, convex enteric-coated tablets imprinted with the logo of "ZA06" on one side and plain on other side and are supplied as follows: NDC 65841-636-01 in bottles of 100 tablets NDC 65841-636-05 in bottles of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant container.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 002bd53e-88c1-441b-acfb-09128b26adc8
34391-3
Set id: a221e493-2e44-4398-90dd-80b348f3f0c2
Version: 9
Effective Time: 20230921
Zydus Lifesciences Limited

Toote omadused

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
ZYDUS LIFESCIENCES LIMITED
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DIVALPROEX SODIUM DELAYED-RELEASE TABLETS SAFELY
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-634-01 in bottle of 100 tablets
Divalproex Sodium Delayed-release Tablets USP, 125 mg
Rx only
100 tablets
NDC 65841-635-01 in bottle of 100 tablets
Divalproex Sodium Delayed-release Tablets USP, 250 mg
Rx only
100 tablets
NDC 65841-636-01 in bottle of 100 tablets
Divalproex Sodium Delayed-release Tablets USP, 500 mg
Rx only
100 tablets
DIVALPROEX SODIUM
divalproex sodium tablet, delayed release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-634
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
VALPROIC ACID
125 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF WHITE)
SCORE
no score
SHAPE
OVAL (OVAL)
SIZE
12mm
FLAVOR
IMPRINT CODE
Z A08
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-634-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
03/06/2010
2
NDC:65841-634-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
03/06/2010
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETIN