Zonisamide
- Product NDC
- 62756-258
- 11-digit product format
- 627560258
- Labeler code
- 62756
- Product ID
- 62756-258_d0c9002b-fa32-4ca8-862f-5286746df2cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077634
- Marketing category
- ANDA
- Marketing start
- 2006-03-17
- Substance
- ZONISAMIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 62756-258 | 62756-258-02 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077634-001 | ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-03-17 | ||
| A077634-002 | ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-03-17 | ||
| A077634-003 | ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-03-17 |
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 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-03-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-03-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-03-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-03-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-03-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-03-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-03-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-03-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-03-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077634-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-03-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077634-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-03-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077634-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-03-17 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077634-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077634-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077634-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077634-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077634-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077634-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077634-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077634-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077634-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077634-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077634-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077634-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077634-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077634-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077634-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077634-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077634-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077634-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077634-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077634-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077634-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077634-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077634-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077634-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077634-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077634-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077634-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077634-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077634-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077634-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077634-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077634-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077634-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077634-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077634-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077634-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077634-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077634-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077634-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077634-001 | AB | 1 | 4b0b4de00fa7… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zonisamide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZONISAMIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 459384H98V | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3164d438-90bf-420a-9a56-5498b987f91c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ca446c7-87bf-4d4c-9a5f-4c587ab0290f | Product name | 1 | 20230316 |
| c27132c2-a1b9-fc49-b84e-22e55312d19e | Product name | 2 | 20210621 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62756-258-01 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | 10 | |
| 62756-258-02 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | 10 | |
| 62756-258-03 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | 10 | |
| 62756-258-04 | Zonisamide | 1000 in 1 BOTTLE | CAPSULE | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62756-258-02 | EA - Each | 62756-258 | 28d07746-0eda-4d57-b417-3ff7214b59de | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Zonisamide | ZONISAMIDE | Bryant Ranch Prepack | 467a73f0-1cd1-46bf-83b3-ee38badb761c | 2026-07-14 | Warnings, Adverse reactions | 077634 ANDA077634 |
| Zonisamide | ZONISAMIDE | Bryant Ranch Prepack | 6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d | 2026-07-13 | Warnings, Adverse reactions | 077634 ANDA077634 |
| Zonisamide | ZONISAMIDE | Sun Pharmaceutical Industries, Inc. | 3164d438-90bf-420a-9a56-5498b987f91c | 2026-06-04 | Warnings, Adverse reactions | 077634 ANDA077634 62756-258 |
| Zonisamide | ZONISAMIDE | Preferred Pharmaceuticals, Inc. | 53ecba6c-0de4-4e11-81d5-6deac79accd5 | 2025-10-08 | Warnings, Adverse reactions | 077634 ANDA077634 |
| Zonisamide | ZONISAMIDE | Direct_Rx | e64b78d8-79de-337b-e053-2a95a90a4861 | 2025-01-22 | Warnings, Adverse reactions | 077634 ANDA077634 |
| Zonisamide | ZONISAMIDE | Proficient Rx LP | 812582ce-fc7e-44b1-a428-7faa3701c1b8 | 2022-04-01 | Warnings, Adverse reactions | 077634 ANDA077634 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314285 | zonisamide 100 MG Oral Capsule | PSN | 3164d438-90bf-420a-9a56-5498b987f91c | 10 |
| 403966 | zonisamide 25 MG Oral Capsule | PSN | 3164d438-90bf-420a-9a56-5498b987f91c | 10 |
| 403967 | zonisamide 50 MG Oral Capsule | PSN | 3164d438-90bf-420a-9a56-5498b987f91c | 10 |
| 314285 | zonisamide 100 MG Oral Capsule | SCD | 3164d438-90bf-420a-9a56-5498b987f91c | 10 |
| 403966 | zonisamide 25 MG Oral Capsule | SCD | 3164d438-90bf-420a-9a56-5498b987f91c | 10 |
| 403967 | zonisamide 50 MG Oral Capsule | SCD | 3164d438-90bf-420a-9a56-5498b987f91c | 10 |
| 403966 | zonisamide 25 MG Oral Capsule | PSN | e64b78d8-79de-337b-e053-2a95a90a4861 | 2 |
| 403966 | zonisamide 25 MG Oral Capsule | SCD | e64b78d8-79de-337b-e053-2a95a90a4861 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62756-258-01 | 62756025801 | 30 CAPSULE in 1 BOTTLE (62756-258-01) | 30 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |
| 62756-258-02 | 62756025802 | 100 CAPSULE in 1 BOTTLE (62756-258-02) | 100 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |
| 62756-258-03 | 62756025803 | 100 CAPSULE in 1 BOTTLE (62756-258-03) | 100 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |
| 62756-258-04 | 62756025804 | 1000 CAPSULE in 1 BOTTLE (62756-258-04) | 1000 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |