DIVALPROEX SODIUM capsule, coated pellets

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 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

  Divalproex sodium delayed-release capsules (sprinkle) are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules (sprinkle) are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.    Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not

Product summary:

Divalproex sodium delayed-release capsules, USP (sprinkle) equivalent to 125 mg of valproic acid are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with blue colored cap  printed with "ZA66" in black ink and white body printed with "125mg" in black ink and are supplied as follows: NDC 65841-639-01 in bottle of 100 capsules NDC 65841-639-10 in bottle of 1,000 capsules NDC 65841-639-77 in unit dose blister carton of 100 (10 x 10) Unit dose capsules Storage : Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].  Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 4b6824bc-0244-4add-9e76-e8ae780c9cf2
34391-3
Set id: b0f33792-dd96-40cc-a28e-acdcdca2f4b8
Version: 8
Effective Time: 20230921
Zydus Lifesciences Limited

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM CAPSULE, COATED PELLETS
ZYDUS LIFESCIENCES LIMITED
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DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-639-01 in bottle of 100 Capsules
Divalproex sodium delayed-release capsules, USP (sprinkle)
Rx only
100 capsules
DIVALPROEX SODIUM
divalproex sodium capsule, coated pellets
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-639
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
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHACRYLIC ACID (UNII: 1CS02G8656)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
BLUE (BLUE) , WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
22mm
FLAVOR
IMPRINT CODE
Z A66;125mg
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
639-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
01/27/2009
2
NDC:65841-
639-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
01/27/2009
3
NDC:65841-
639-30
10 in 1 CARTON
01/27/2009
3
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
Zydus Lifesciences Limited
ANDA
ANDA078919
01/27/2009
LABELER -
Zydus Lifescien