Divalproex Sodium Extended-Release
- Product NDC
- 64725-0315
- 11-digit product format
- 647250315
- Labeler code
- 64725
- Product ID
- 64725-0315_af3febff-f6b0-4bb3-9f83-142ef96135e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- NDA021168
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-08-12
- Marketing end
- 0000-00-00
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b10a892b-b985-4cbc-9547-9ac4b72b784f | Product name | 2 | 20250818 |
| 7a3a03f1-382a-f9ec-0741-ff24dcbfed69 | Product name | 7 | 20250624 |
| 57fc3d01-4737-4091-9728-9e8a4c9e708d | Product name | 1 | 20200121 |
| 5d67ecc7-47c7-ec5e-e9eb-71bf00250645 | Product name | 1 | 20140508 |
| 97fce1a8-50c4-f088-0e31-64d82b6e9081 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-0315-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4488-60a7-e053-dbdaa90a05bd | 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0315-1 | Divalproex Sodium Extended-Release | 15 in 1 CONTAINER | TABLET, EXTENDED RELEASE | 15 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS] | 4 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0315 | DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS] | 4 | Legacy NDC, 1 package rows | 20140921_49a585a8-327a-44b2-b45b-7a0959724dc6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1099563 | divalproex sodium 250 MG 24HR Extended Release Oral Tablet | PSN | 49a585a8-327a-44b2-b45b-7a0959724dc6 | 4 |
| 1099569 | divalproex sodium 500 MG 24HR Extended Release Oral Tablet | PSN | 49a585a8-327a-44b2-b45b-7a0959724dc6 | 4 |
| 1099563 | 24 HR divalproex sodium 250 MG Extended Release Oral Tablet | SCD | 49a585a8-327a-44b2-b45b-7a0959724dc6 | 4 |
| 1099569 | 24 HR divalproex sodium 500 MG Extended Release Oral Tablet | SCD | 49a585a8-327a-44b2-b45b-7a0959724dc6 | 4 |
| 1099563 | divalproex sodium 250 MG 24 HR Extended Release Oral Tablet | SY | 49a585a8-327a-44b2-b45b-7a0959724dc6 | 4 |
| 1099569 | divalproex sodium 500 MG 24 HR Extended Release Oral Tablet | SY | 49a585a8-327a-44b2-b45b-7a0959724dc6 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0315-1 | 64725031501 | 15 in 1 CONTAINER | Historical |