NDC 70518-1456
Depakote
Divalproex Sodium
Depakote is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Divalproex Sodium.
| Product ID | 70518-1456_774aba77-e69a-0e0a-e053-2991aa0a8083 |
| NDC | 70518-1456 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Depakote |
| Generic Name | Divalproex Sodium |
| Dosage Form | Tablet, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-02 |
| Marketing Category | NDA / NDA |
| Application Number | NDA018723 |
| Labeler Name | REMEDYREPACK INC. |
| 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 | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 70518-1456-0
30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1456-0)
| Marketing Start Date | 2018-10-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70518-1456-0 [70518145600]
Depakote TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA018723 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-02 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DIVALPROEX SODIUM | 500 mg/1 |
OpenFDA Data
| SPL SET ID: | 86fd7d4d-20d4-4483-8e45-f2942503f367 |
| 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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