Divalproex sodium
- Product NDC
- 46708-821
- 11-digit product format
- 467080821
- Labeler code
- 46708
- Product ID
- 46708-821_f34c4504-5409-406e-995b-138e5f700242
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex sodium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA218793
- Marketing category
- ANDA
- Marketing start
- 2024-12-23
- 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 | 1099596 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-821-10 | Divalproex sodium | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | | 1 |
| 46708-821-10 | Divalproex sodium | 100 in 1 CARTON | CAPSULE, DELAYED RELEASE | 100 | | 1 |
| 46708-821-31 | Divalproex sodium | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 1 |
| 46708-821-91 | Divalproex sodium | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-821 | DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20250112_f34c4504-5409-406e-995b-138e5f700242.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-821-10 | 46708082110 | 100 BLISTER PACK in 1 CARTON (46708-821-10) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 100 blister pack | 2024-12-23 | No | No | Current |
| 46708-821-31 | 46708082131 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-31) | | 2024-12-23 | No | No | Current |
| 46708-821-91 | 46708082191 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-91) | | 2024-12-23 | No | No | Current |