Label: DIVALPROEX SODIUM tablet, film coated, extended release
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NDC Code(s):
65841-637-01,
65841-637-05,
65841-637-14,
65841-637-16, view more65841-638-01, 65841-638-05, 65841-638-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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INGREDIENTS AND APPEARANCE
DIVALPROEX SODIUM
divalproex sodium tablet, film coated, extended releaseProduct 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 ZA47 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 Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078239 01/07/2013 DIVALPROEX SODIUM
divalproex sodium tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-638 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 500 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 23mm Flavor Imprint Code ZA48 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-638-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/07/2013 2 NDC:65841-638-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/07/2013 3 NDC:65841-638-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/07/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078239 01/07/2013 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-637, 65841-638) , MANUFACTURE(65841-637, 65841-638)
