Divalproex Sodium
- Product NDC
- 0904-6363
- 11-digit product format
- 009046363
- Labeler code
- 0904
- Product ID
- 0904-6363_7b77fe8c-7100-4756-90ce-0dba2543d9e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090161
- Marketing category
- ANDA
- Marketing start
- 2013-08-11
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090161-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090161-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090161-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2012-03-15 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090161-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090161-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090161-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090161-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090161-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090161-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090161-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090161-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090161-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090161-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090161-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090161-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090161-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090161-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090161-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090161-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090161-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090161-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090161-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090161-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090161-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090161-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090161-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090161-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090161-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090161-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090161-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090161-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090161-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090161-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090161-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090161-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090161-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090161-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090161-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090161-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090161-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090161-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090161-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090161-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|
| 1099563 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b10a892b-b985-4cbc-9547-9ac4b72b784f | Product name | 2 | 20250818 |
| 7a3a03f1-382a-f9ec-0741-ff24dcbfed69 | Product name | 7 | 20250624 |
| 57fc3d01-4737-4091-9728-9e8a4c9e708d | Product name | 1 | 20200121 |
| 5d67ecc7-47c7-ec5e-e9eb-71bf00250645 | Product name | 1 | 20140508 |
| 97fce1a8-50c4-f088-0e31-64d82b6e9081 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-6363-45 | Divalproex Sodium | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 15 | |
| 0904-6363-45 | Divalproex Sodium | 80 in 1 CARTON | TABLET, EXTENDED RELEASE | 80 | 15 | |
| 0904-6363-61 | Divalproex Sodium | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 15 | |
| 0904-6363-61 | Divalproex Sodium | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6363-45 | EA - Each | 0904-6363 | 74cddd8f-a795-4f52-8b92-78af515d22e1 | 1 | 2015-01-05 |
| 0904-6363-61 | EA - Each | 0904-6363 | 73ddf05e-9f43-4839-bcf4-37098942e363 | 1 | 2017-11-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Dr. Reddy's Laboratories Ltd | 2e35f833-1cf7-12eb-9567-7a191e32e138 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 090161 ANDA090161 |
| Divalproex Sodium | DIVALPROEX SODIUM | Major Pharmaceuticals | 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 090161 ANDA090161 0904-6363 |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 74a9f020-f7a1-44e2-a452-f0e37bd3e077 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 090161 ANDA090161 |
| Divalproex Sodium | DIVALPROEX SODIUM | Coupler LLC | 533245ba-7088-c929-e063-6294a90abe1d | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 090161 ANDA090161 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1099563 | divalproex sodium 250 MG 24HR Extended Release Oral Tablet | PSN | 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0 | 15 |
| 1099563 | 24 HR divalproex sodium 250 MG Extended Release Oral Tablet | SCD | 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0 | 15 |
| 1099563 | divalproex sodium 250 MG 24 HR Extended Release Oral Tablet | SY | 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6363-45 | 00904636345 | 80 BLISTER PACK in 1 CARTON (0904-6363-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 80 blister pack | 2013-08-11 | 0000-00-00 | No | No | Current |
| 0904-6363-61 | 00904636361 | 100 BLISTER PACK in 1 CARTON (0904-6363-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2013-08-11 | 0000-00-00 | No | No | Current |