NDC 21695-163
Depakote
Divalproex Sodium
Depakote is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Divalproex Sodium.
| Product ID | 21695-163_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4 |
| NDC | 21695-163 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Depakote |
| Generic Name | Divalproex Sodium |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-06-07 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021168 |
| Labeler Name | Rebel Distributors Corp |
| Substance Name | DIVALPROEX SODIUM |
| Active Ingredient Strength | 500 mg/1 |
| Pharm 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 |
Packaging
NDC 21695-163-15
15 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-163-15)
| Marketing Start Date | 2010-06-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 21695-163-15 [21695016315]
Depakote TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA021168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-06-07 |
| Inactivation Date | 2019-09-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DIVALPROEX SODIUM | 500 mg/1 |
OpenFDA Data
| SPL SET ID: | bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Anti-epileptic Agent [EPC]
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Mood Stabilizer [EPC]
NDC Crossover Matching brand name "Depakote" or generic name "Divalproex Sodium"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0074-3826 | Depakote | Divalproex Sodium |
| 0074-6114 | Depakote | Divalproex Sodium |
| 0074-6212 | Depakote | Divalproex Sodium |
| 0074-6214 | Depakote | Divalproex Sodium |
| 0074-6215 | Depakote | Divalproex Sodium |
| 0074-7126 | Depakote | Divalproex Sodium |
| 70518-1456 | Depakote | Depakote |
| 70518-1454 | Depakote | Depakote |
| 21695-359 | Depakote | Depakote |
| 21695-163 | Depakote | Depakote |
Trademark Results [Depakote]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DEPAKOTE 75295484 2197507 Dead/Cancelled |
SANOFI-AVENTIS 1997-05-21 |
 DEPAKOTE 73383028 1377834 Live/Registered |
SANOFI 1982-09-01 |
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