Divalproex sodium
- Product NDC
- 71335-2535
- 11-digit product format
- 713352535
- Labeler code
- 71335
- Product ID
- 71335-2535_41db30e4-4563-57fd-e063-6294a90a4cfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215527
- Marketing category
- ANDA
- Marketing start
- 2023-09-26
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2535_41db30e4-4563-57fd-e063-6294a90a4cfe
- SPL ID
- 41db30e4-4563-57fd-e063-6294a90a4cfe
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Divalproex sodium
- Generic name
- Divalproex sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing start
- 2023-09-26
- Marketing category
- ANDA
- Application number
- ANDA215527
- Pharmacologic classes
- Anti-epileptic Agent [EPC]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; Mood Stabilizer [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| DIVALPROEX SODIUM | 500 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 644VL95AO6 |
| Rxcui | 1099569 |
| Spl Set Id | d524db34-99c4-4837-a532-a619f82c21ba |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2535-1 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1) | 2024-12-10 | No |
| 71335-2535-2 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2) | 2024-12-10 | No |
| 71335-2535-3 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3) | 2024-12-10 | No |
| 71335-2535-4 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4) | 2024-12-10 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 644VL95AO6 | DIVALPROEX SODIUM | 76584-70-8 | DIVALPROEX SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2535-1 | 71335253501 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1) | 2024-12-10 | No | No | Historical |
| 71335-2535-2 | 71335253502 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2) | 2024-12-10 | No | No | Historical |
| 71335-2535-3 | 71335253503 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3) | 2024-12-10 | No | No | Historical |
| 71335-2535-4 | 71335253504 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4) | 2024-12-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Divalproex sodium | Bryant Ranch Prepack | 2025-10-23 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| Divalproex sodium | Bryant Ranch Prepack | 2024-12-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |