Divalproex sodium
- Product NDC
- 70518-3477
- 11-digit product format
- 705183477
- Labeler code
- 70518
- Product ID
- 70518-3477_4f1bb8ce-7bd8-a202-e063-6294a90aa8b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209286
- Marketing category
- ANDA
- Marketing start
- 2022-08-16
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3477-0 | Divalproex sodium | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 12 |
| 70518-3477-1 | Divalproex sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 12 |
| 70518-3477-2 | Divalproex sodium | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 12 |
| 70518-3477-3 | Divalproex sodium | 100 in 1 BOX | TABLET, EXTENDED RELEASE | 100 | | 12 |
| 70518-3477-4 | Divalproex sodium | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 12 |
| 70518-3477-5 | Divalproex sodium | 100 in 1 BOX | TABLET, EXTENDED RELEASE | 100 | | 12 |
| 70518-3477-6 | Divalproex sodium | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3477 | DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 7 package rows | 20241006_6af40b06-0a92-454c-9277-80e89de27231.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3477-0 | 70518347700 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3477-0) | | 2022-08-16 | 0000-00-00 | No | No | Current |
| 70518-3477-1 | 70518347701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3477-1) | | 2022-10-14 | 0000-00-00 | No | No | Current |
| 70518-3477-2 | 70518347702 | 30 in 1 BLISTER PACK | | | | | | Historical |
| 70518-3477-3 | 70518347703 | 100 POUCH in 1 BOX (70518-3477-3) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-4) | 100 pouch | 2023-05-17 | | No | No | Current |
| 70518-3477-4 | 70518347704 | 1 in 1 POUCH | | | | | | Historical |
| 70518-3477-5 | 70518347705 | 100 POUCH in 1 BOX (70518-3477-5) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-6) | 100 pouch | 2023-08-23 | | No | No | Current |
| 70518-3477-6 | 70518347706 | 1 in 1 POUCH | | | | | | Historical |