Divalproex Sodium
- Product NDC
- 0378-0472
- 11-digit product format
- 003780472
- Labeler code
- 0378
- Product ID
- 0378-0472_346235bd-f9cb-4693-9ad2-d62cbe9c62ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- divalproex sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA077567
- Marketing category
- ANDA
- Marketing start
- 2009-01-29
- 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
- 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 644VL95AO6 |
| Rxcui | 1099563, 1099569 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0378-0472-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
| 0378-0472-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4446-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0472-01 | Divalproex Sodium | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 100 | | 39 |
| 0378-0472-05 | Divalproex Sodium | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 500 | | 39 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0472 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 33 | Current NDC, Legacy NDC, 2 package rows | 20250228_00332c65-edad-a153-9c78-628931daa732.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0472-01 | 00378047201 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-01) | 2009-01-29 | 0000-00-00 | No | No | Current |
| 0378-0472-05 | 00378047205 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-05) | 2009-01-29 | 0000-00-00 | No | No | Current |
| 0378-0472-77 | 00378047277 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-77) | 2010-03-30 | 0000-00-00 | No | No | Current |