Divalproex Sodium
- Product NDC
- 48433-034
- 11-digit product format
- 484330034
- Labeler code
- 48433
- Product ID
- 48433-034_4c9884d8-fb27-d53c-e063-6294a90a4fe9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- divalproex sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA077567
- Marketing category
- ANDA
- Marketing start
- 2026-02-24
- Substance
- DIVALPROEX SODIUM
- Active strength
- 500 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Divalproex Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIVALPROEX SODIUM | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 644VL95AO6 |
| Rxcui | 1099563, 1099569 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-034-01 | Divalproex Sodium | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 2 |
| 48433-034-08 | Divalproex Sodium | 80 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 80 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-034-01 | 48433003401 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-034-08 | 48433003408 | 80 BLISTER PACK in 1 CARTON (48433-034-08) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (48433-034-01) | 80 blister pack | 2026-02-24 | No | No | Historical |