divalproex sodium
- Product NDC
- 55111-529
- 11-digit product format
- 551110529
- Labeler code
- 55111
- Product ID
- 55111-529_be502229-0e61-8481-dda9-794c93637dd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- divalproex sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA078755
- Marketing category
- ANDA
- Marketing start
- 2008-07-29
- Substance
- DIVALPROEX SODIUM
- Active strength
- 125 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 | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 644VL95AO6 |
| Rxcui | 1099625, 1099678, 1099870 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-529-01 | divalproex sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 4 |
| 55111-529-05 | divalproex sodium | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | | 4 |
| 55111-529-30 | divalproex sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 4 |
| 55111-529-78 | divalproex sodium | 10 in 1 CARTON | TABLET, DELAYED RELEASE | 10 | | 4 |
| 55111-529-79 | divalproex sodium | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| divalproex sodium | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| Valproic acid | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| Acetone | INACTIVE INGREDIENT | 1364PS73AF | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| butyl alcohol | INACTIVE INGREDIENT | 8PJ61P6TS3 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| hypromellose phthalate (31% phthalate, 40 CST) | INACTIVE INGREDIENT | G4U024CQK6 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| lecithin, soybean | INACTIVE INGREDIENT | 1DI56QDM62 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| methylene chloride | INACTIVE INGREDIENT | 588X2YUY0A | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| shellac | INACTIVE INGREDIENT | 46N107B71O | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
| vanillin | INACTIVE INGREDIENT | CHI530446X | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-529 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED] | 4 | Current NDC, Legacy NDC, 5 package rows | 20190312_15f8a5be-e269-2e07-60d9-1dd7bf5f5281.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 |
|---|
| 55111-529-01 | 55111052901 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-01) | | 2008-07-29 | 0000-00-00 | No | No | Current |
| 55111-529-05 | 55111052905 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-05) | | 2008-07-29 | 0000-00-00 | No | No | Current |
| 55111-529-30 | 55111052930 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-30) | | 2008-07-29 | 0000-00-00 | No | No | Current |
| 55111-529-78 | 55111052978 | 10 BLISTER PACK in 1 CARTON (55111-529-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-529-79) | 10 blister pack | 2008-07-29 | 0000-00-00 | No | No | Current |
| 55111-529-79 | 55111052979 | 10 in 1 BLISTER PACK | | | | | | Historical |