Depakote
- Product NDC
- 0074-7402
- 11-digit product format
- 000747402
- Labeler code
- 0074
- Product ID
- 0074-7402_0ee65b66-ead3-44ef-911f-14965b067903
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AbbVie Inc.
- Application
- NDA021168
- Marketing category
- NDA
- Marketing start
- 2000-08-04
- 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 |
|---|---|---|---|---|---|---|---|
| N021168-001 | DEPAKOTE ER | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 |
| N021168-002 | DEPAKOTE ER | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021168-001 | AB |
| N021168-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2000-08-04 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-08-04 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-08-04 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-08-04 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-08-04 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021168-001 | DEPAKOTE ER | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-08-04 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021168-002 | DEPAKOTE ER | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2002-05-31 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021168-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021168-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021168-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021168-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021168-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021168-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021168-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021168-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021168-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021168-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021168-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021168-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021168-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021168-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021168-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021168-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021168-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021168-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021168-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021168-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021168-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021168-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021168-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021168-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021168-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021168-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021168-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021168-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021168-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021168-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021168-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021168-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021168-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021168-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021168-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021168-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021168-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021168-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021168-002 | AB | 1 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | 6419953*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | 6511678*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | 6528090*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | 6528091*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | 6713086*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-001 | 6720004*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-002 | 6511678*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-002 | 6528090*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-002 | 6713086*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021168-002 | 6720004*PED | 2019-06-18 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-001 | 6419953*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-001 | 6511678*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-001 | 6528090*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-001 | 6528091*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-001 | 6713086*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-001 | 6720004*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-002 | 6511678*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-002 | 6528090*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-002 | 6713086*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021168-002 | 6720004*PED | 2019-06-18 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-001 | 6419953*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-001 | 6511678*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-001 | 6528090*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-001 | 6528091*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-001 | 6713086*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-001 | 6720004*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-002 | 6511678*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-002 | 6528090*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-002 | 6713086*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021168-002 | 6720004*PED | 2019-06-18 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-001 | 6419953*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-001 | 6511678*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-001 | 6528090*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-001 | 6528091*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-001 | 6713086*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-001 | 6720004*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-002 | 6511678*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-002 | 6528090*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-002 | 6713086*PED | 2019-06-18 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021168-002 | 6720004*PED | 2019-06-18 | Pediatric extension | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Depakote
- Brand name suffix
- ER
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIVALPROEX SODIUM | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 644VL95AO6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0dc024ce-efc8-4690-7cb5-639c728fccac | 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 |
|---|---|---|---|---|---|---|
| 0074-7402-13 | DepakoteER | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 1658 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0074-7402-13 | EA - Each | 0074-7402 | c96fff8d-ebe1-48d9-94e6-263f284ad7cc | 1 | 2022-05-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [ABBVIE INC.] | 1571 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [ABBVIE INC.] | 1571 |
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 |
|---|---|---|---|---|---|---|
| Depakote ER | DIVALPROEX SODIUM | AbbVie Inc. | 0dc024ce-efc8-4690-7cb5-639c728fccac | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 021168 NDA021168 0074-7402 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1099565 | Depakote ER 250 MG 24HR Extended Release Oral Tablet | PSN | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099571 | Depakote ER 500 MG 24HR Extended Release Oral Tablet | PSN | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099563 | divalproex sodium 250 MG 24HR Extended Release Oral Tablet | PSN | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099569 | divalproex sodium 500 MG 24HR Extended Release Oral Tablet | PSN | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099565 | 24 HR divalproex sodium 250 MG Extended Release Oral Tablet [Depakote] | SBD | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099571 | 24 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote] | SBD | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099563 | 24 HR divalproex sodium 250 MG Extended Release Oral Tablet | SCD | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099569 | 24 HR divalproex sodium 500 MG Extended Release Oral Tablet | SCD | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099565 | 24 HR Depakote 250 MG Extended Release Oral Tablet | SY | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099571 | 24 HR Depakote 500 MG Extended Release Oral Tablet | SY | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099565 | Depakote 250 MG 24 HR Extended Release Oral Tablet | SY | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099571 | Depakote 500 MG 24 HR Extended Release Oral Tablet | SY | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099563 | divalproex sodium 250 MG 24 HR Extended Release Oral Tablet | SY | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
| 1099569 | divalproex sodium 500 MG 24 HR Extended Release Oral Tablet | SY | 0dc024ce-efc8-4690-7cb5-639c728fccac | 1658 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0074-7402-13 | 00074740213 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7402-13) | 2000-08-04 | 0000-00-00 | No | No | Current |