Label: DIVALPROEX SODIUM capsule, coated pellets
- NDC Code(s): 65841-639-01, 65841-639-10, 65841-639-30
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2023
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INGREDIENTS AND APPEARANCE
DIVALPROEX SODIUM
divalproex sodium capsule, coated pelletsProduct 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 ZA66;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 ANDA ANDA078919 01/27/2009 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-639) , MANUFACTURE(65841-639)
