País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
Zydus Lifesciences Limited
DIVALPROEX SODIUM
VALPROIC ACID 125 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
Zydus Lifesciences Limited ---------- 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 Leia o documento completo
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE ZYDUS LIFESCIENCES LIMITED ---------- 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 Leia o documento completo