divalproex sodium
- Product NDC
- 68788-4193
- Requested package NDC
- 68788-4193-3
- 11-digit product format
- 687884193
- Labeler code
- 68788
- Product ID
- 68788-4193_2de86096-4ec7-47df-94db-9c7f6e5df424
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- divalproex sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA214643
- Marketing category
- ANDA
- Marketing start
- 2026-09-24
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214643-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | |
| A214643-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214643-001 | AB |
| A214643-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 4b0b4de00fa7… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214643-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214643-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2022-02-25 | 6a51e52b5d6a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214643-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214643-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214643-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214643-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214643-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214643-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214643-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214643-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214643-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214643-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214643-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214643-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214643-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214643-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214643-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214643-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214643-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214643-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214643-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214643-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214643-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214643-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214643-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214643-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214643-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214643-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214643-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214643-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214643-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214643-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214643-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A214643-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214643-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214643-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A214643-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A214643-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A214643-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A214643-002 | AB | 1 | 4b0b4de00fa7… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214643-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214643-002 | AB | 1 | 6a51e52b5d6a… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- divalproex sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIVALPROEX SODIUM | 500 mg/1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| divalproex sodium | DIVALPROEX SODIUM | BluePoint Laboratories | 352b4c3c-e419-4827-9e00-febb0164e0f5 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 214643 ANDA214643 |
| divalproex sodium | DIVALPROEX SODIUM | Unichem Pharmaceuticals (USA), Inc. | 1d4129ae-0ce8-4a04-9f9d-c770508de8ed | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 214643 ANDA214643 |
| divalproex sodium | DIVALPROEX SODIUM | American Health Packaging | b12b76a0-4b6e-4cd4-9508-10a2c84d8beb | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 214643 ANDA214643 |
| divalproex sodium | DIVALPROEX SODIUM | A-S Medication Solutions | e5fcf5b1-263e-43e0-9424-e613d5cca3fa | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 214643 ANDA214643 |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 46b2e8a9-5d50-d0b2-e063-6294a90a1b47 | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | 214643 ANDA214643 |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 3eee54a6-5b4c-330d-e063-6394a90a9f18 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 214643 ANDA214643 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68788-4193-3 | 68788419303 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-4193-3) | 2026-09-24 | No | No | Current |