Zonisamide
- Product NDC
- 68071-4152
- Requested package NDC
- 68071-4152-3
- 11-digit product format
- 680714152
- Labeler code
- 68071
- Product ID
- 68071-4152_bb62996a-956e-1d43-e053-2995a90a2476
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077651
- Marketing category
- ANDA
- Marketing start
- 2006-01-30
- Marketing end
- 0000-00-00
- Substance
- ZONISAMIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 68071-4152 | 68071-4152-3 | D | Discontinued by firm | 2026-08-03 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077651-001 | ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | |
| A077651-002 | ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | |
| A077651-003 | ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077651-001 | AB |
| A077651-002 | AB |
| A077651-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077651-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-01-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077651-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-01-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077651-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-01-30 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077651-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077651-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077651-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077651-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077651-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077651-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077651-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077651-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077651-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077651-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077651-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077651-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077651-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077651-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077651-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077651-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077651-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077651-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077651-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077651-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077651-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077651-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077651-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077651-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077651-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077651-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077651-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077651-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077651-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077651-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077651-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077651-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077651-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077651-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077651-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077651-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077651-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077651-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077651-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077651-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
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 |
|---|---|---|---|---|---|---|
| Zonisamide | ZONISAMIDE | REMEDYREPACK INC. | 50bb1a0a-a66d-4a13-a456-a10c1b8c8e94 | 2026-05-27 | Warnings, Adverse reactions | 077651 ANDA077651 |
| Zonisamide | ZONISAMIDE | BluePoint Laboratories | 345efcc4-6a36-4ddf-8b6c-9c6c844dab0a | 2026-03-04 | Warnings, Adverse reactions | 077651 ANDA077651 |
| Zonisamide | ZONISAMIDE | Bryant Ranch Prepack | 1a859304-804a-4588-9961-c2e6ae09aadb | 2025-11-26 | Warnings, Adverse reactions | 077651 ANDA077651 |
| Zonisamide | ZONISAMIDE | Glenmark Pharmaceuticals Inc., USA | fe15e56e-8b86-4a65-825c-31d37dd81612 | 2025-10-27 | Warnings, Adverse reactions | 077651 ANDA077651 |
| Zonisamide | ZONISAMIDE | Proficient Rx LP | 85321a9a-08d9-49e4-8c79-86ecfc536613 | 2022-10-01 | Warnings, Adverse reactions | 077651 ANDA077651 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4152-3 | 68071415203 | 30 CAPSULE in 1 BOTTLE (68071-4152-3) | 30 capsule | 2017-11-08 | 0000-00-00 | No | No | Current |