Divalproex Sodium
- Product NDC
- 55111-533
- 11-digit product format
- 551110533
- Labeler code
- 55111
- Product ID
- 55111-533_bbff7587-1b4e-6616-e6f5-689bc89e1aea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Ltd
- Application
- ANDA090161
- Marketing category
- ANDA
- Marketing start
- 2013-08-11
- Substance
- DIVALPROEX SODIUM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Divalproex Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIVALPROEX SODIUM | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 644VL95AO6 |
| Rxcui | 1099563 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-533-01 | Divalproex Sodium | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 27 |
| 55111-533-05 | Divalproex Sodium | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 27 |
| 55111-533-30 | Divalproex Sodium | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 27 |
| 55111-533-60 | Divalproex Sodium | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 27 |
| 55111-533-78 | Divalproex Sodium | 10 in 1 CARTON | TABLET, EXTENDED RELEASE | 10 | | 27 |
| 55111-533-79 | Divalproex Sodium | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| divalproex sodium | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| valproic acid | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| hydroxyethyl cellulose (2000 CPS AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 12 | |
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-533 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD] | 26 | Current NDC, Legacy NDC, 6 package rows | 20250504_2e35f833-1cf7-12eb-9567-7a191e32e138.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-533-01 | 55111053301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-01) | | 2013-08-11 | 0000-00-00 | No | No | Current |
| 55111-533-05 | 55111053305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-05) | | 2013-08-11 | 0000-00-00 | No | No | Current |
| 55111-533-30 | 55111053330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-30) | | 2013-08-11 | 0000-00-00 | No | No | Current |
| 55111-533-60 | 55111053360 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-60) | | 2013-08-11 | 0000-00-00 | No | No | Current |
| 55111-533-78 | 55111053378 | 10 BLISTER PACK in 1 CARTON (55111-533-78) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-533-79) | 10 blister pack | 2013-08-11 | 0000-00-00 | No | No | Current |
| 55111-533-79 | 55111053379 | 10 in 1 BLISTER PACK | | | | | | Historical |