Divalproex Sodium
- Product NDC
- 0904-6363
- 11-digit product format
- 009046363
- Labeler code
- 0904
- Product ID
- 0904-6363_7b77fe8c-7100-4756-90ce-0dba2543d9e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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 |
|---|
| 0904-6363-45 | Divalproex Sodium | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 15 |
| 0904-6363-45 | Divalproex Sodium | 80 in 1 CARTON | TABLET, EXTENDED RELEASE | 80 | | 15 |
| 0904-6363-61 | Divalproex Sodium | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 15 |
| 0904-6363-61 | Divalproex Sodium | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 15 |
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 [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 |
|---|
| 0904-6363 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 13 | Current NDC, Legacy NDC, 4 package rows | 20250223_4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0.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 |
|---|
| 0904-6363-45 | 00904636345 | 80 BLISTER PACK in 1 CARTON (0904-6363-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 80 blister pack | 2013-08-11 | 0000-00-00 | No | No | Current |
| 0904-6363-61 | 00904636361 | 100 BLISTER PACK in 1 CARTON (0904-6363-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2013-08-11 | 0000-00-00 | No | No | Current |