![DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/a221e493-2e44-4398-90dd-80b348f3f0c2/7735a595-6f13-4367-8988-5560c77ed252-06.jpg)
![DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/a221e493-2e44-4398-90dd-80b348f3f0c2/7735a595-6f13-4367-8988-5560c77ed252-07.jpg)
![DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/a221e493-2e44-4398-90dd-80b348f3f0c2/7735a595-6f13-4367-8988-5560c77ed252-08.jpg)
| NDC | 65841-634-01, 65841-634-05, 65841-635-01, 65841-635-05, 65841-636-01, 65841-636-05 |
| Set ID | a221e493-2e44-4398-90dd-80b348f3f0c2 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Anti-epileptic Agent |
| Product Number | |
| Application Number | ANDA077100 |
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
DIVALPROEX SODIUM
divalproex sodium tablet, delayed releaseProduct 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 ZA08 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 Marketing End Date ANDA ANDA077100 03/06/2010 DIVALPROEX SODIUM
divalproex sodium tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-635 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) 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 14mm Flavor Imprint Code ZA07 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-635-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2010 2 NDC:65841-635-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077100 03/06/2010 DIVALPROEX SODIUM
divalproex sodium tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-636 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) 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 19mm Flavor Imprint Code ZA06 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-636-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2010 2 NDC:65841-636-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077100 03/06/2010 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-634, 65841-635, 65841-636) , MANUFACTURE(65841-634, 65841-635, 65841-636)