Divalproex sodium
- Product NDC
- 68788-8358
- 11-digit product format
- 687888358
- Labeler code
- 68788
- Product ID
- 68788-8358_8640d1fe-87c9-412e-99db-8f4298277daa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA209286
- Marketing category
- ANDA
- Marketing start
- 2023-02-13
- 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 | 1099569 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8358-3 | Divalproex sodium | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 68788-8358-6 | Divalproex sodium | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 4 |
| 68788-8358-9 | Divalproex sodium | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8358 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.] | 3 | Current NDC, 3 package rows | 20250331_83a77f60-ed58-4fa0-a584-e6a0c767d19d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8358-3 | 68788835803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8358-3) | 2023-02-13 | No | No | Historical |
| 68788-8358-6 | 68788835806 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8358-6) | 2023-02-13 | No | No | Historical |
| 68788-8358-9 | 68788835809 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8358-9) | 2023-02-13 | No | No | Historical |