Divalproex Sodium
- Product NDC
- 50090-3416
- 11-digit product format
- 500903416
- Labeler code
- 50090
- Product ID
- 50090-3416_e32ff716-9bf4-4bb6-9d7c-a7c49149f596
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Divalproex Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078182
- Marketing category
- ANDA
- Marketing start
- 2014-03-21
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50090-3416 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50090-3416 | 50090-3416-0 | I | Inactivated by FDA | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-3416-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-3416-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-3416-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-3416-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-3416-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-3416-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-3416-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-3416-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-3416-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-3416-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-3416-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-3416-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-3416-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-3416-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-3416-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078182-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | |
| A078182-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | |
| A078182-003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078182-001 | AB |
| A078182-002 | AB |
| A078182-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078182-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078182-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078182-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078182-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078182-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078182-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078182-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078182-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078182-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078182-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078182-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078182-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078182-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078182-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078182-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078182-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078182-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078182-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078182-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078182-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078182-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078182-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078182-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078182-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078182-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078182-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078182-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078182-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078182-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078182-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078182-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078182-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078182-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078182-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078182-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078182-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078182-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078182-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078182-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078182-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078182-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078182-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078182-001 | AB | 1 | 1e350fbaab3a… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3416-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-aa22-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS DIVALPROEX SODIUM delayed-release tablets for oral use Initial U.S. Approval: 1983 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3416-0 | Divalproex Sodium | 100 in 1 CARTON | TABLET, DELAYED RELEASE | 100 | 1 | |
| 50090-3416-0 | Divalproex Sodium | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3416-0 | EA - Each | 50090-3416 | 3757c04e-4e4d-4f0e-8eb9-8108e1238cfe | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3416 | DIVALPROEX SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190205_f1132762-3878-4f77-82cd-ec0f4e0056f3.zip |
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 | Cardinal Health 107, LLC | 4fc50afb-67f3-4bf3-9ec3-cc12734f47fd | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 078182 ANDA078182 |
| Divalproex Sodium | DIVALPROEX SODIUM | Upsher-Smith Laboratories, LLC | 02304a23-4a5f-47bc-9687-4044b43f7a20 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 078182 ANDA078182 |
| Divalproex Sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | b74adc5e-e92d-46a7-afdc-a6464a440bde | 2018-02-16 | Boxed warning, Warnings, Adverse reactions | 078182 ANDA078182 |
| Divalproex Sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 9cfdcb58-d6d7-43bb-b6e1-17172b143296 | 2018-02-16 | Boxed warning, Warnings, Adverse reactions | 078182 ANDA078182 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1099678 | divalproex sodium 250 MG Delayed Release Oral Tablet | PSN | f1132762-3878-4f77-82cd-ec0f4e0056f3 | 1 |
| 1099678 | divalproex sodium 250 MG Delayed Release Oral Tablet | SCD | f1132762-3878-4f77-82cd-ec0f4e0056f3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-3416-0 | 50090341600 | 100 BLISTER PACK in 1 CARTON (50090-3416-0) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 100 blister pack | 2018-03-26 | 0000-00-00 | No | No | Current |