divalproex sodium
- Product NDC
- 67046-1683
- Requested package NDC
- 67046-1683-3
- 11-digit product format
- 670461683
- Labeler code
- 67046
- Product ID
- 67046-1683_55f16081-a4a8-452c-e063-6294a90afb93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- divalproex sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA078853
- Marketing category
- ANDA
- Marketing start
- 2026-07-06
- Substance
- DIVALPROEX SODIUM
- Active strength
- 250 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 |
|---|---|---|---|---|---|---|---|
| A078853-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | |
| A078853-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | |
| A078853-003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078853-001 | AB |
| A078853-002 | AB |
| A078853-003 | 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 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078853-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078853-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078853-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-11-25 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078853-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078853-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078853-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078853-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078853-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078853-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078853-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078853-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078853-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078853-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078853-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078853-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078853-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078853-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078853-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078853-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078853-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078853-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078853-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078853-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078853-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078853-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078853-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078853-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078853-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078853-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078853-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078853-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078853-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078853-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078853-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078853-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078853-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078853-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078853-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078853-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078853-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078853-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078853-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078853-001 | AB | 1 | 301d65b070ca… |
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 | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 644VL95AO6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1099678 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55f1614b-aadc-34ca-e063-6394a90ae2a7 | Available on FDA.report |
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 | Coupler LLC | 55f1614b-aadc-34ca-e063-6394a90ae2a7 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 67046-1683-3 67046-1683 67046168303 |
| divalproex sodium | DIVALPROEX SODIUM | Bionpharma Inc. | 19064624-81d1-4ce3-bfe4-955bad6af6a2 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | c971b50d-0f78-422f-abee-1c5b4e1d20e7 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | Preferred Pharmaceuticals Inc. | dbd1d178-77a3-46ff-985d-307dffaed1ad | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 4834732f-6044-946c-e063-6394a90a5da3 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | f936b9d0-a58f-4fa5-8db9-752dabb837a6 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | A-S Medication Solutions | ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | df8f3825-a037-4343-859d-e59bca5f1e43 | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
| divalproex sodium | DIVALPROEX SODIUM | Proficient Rx LP | 15ffe3d8-d483-4c45-adc4-1cc8a5b68d19 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | 078853 ANDA078853 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 67046-1683-3 | 67046168303 | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1683-3) | 2026-07-06 | No | No | Current |