zonisamide
- Product NDC
- 70518-3180
- 11-digit product format
- 705183180
- Labeler code
- 70518
- Product ID
- 70518-3180_c8d185b0-89f3-7155-e053-2995a90aa2f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077869
- Marketing category
- ANDA
- Marketing start
- 2021-08-04
- 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 product | product | 70518-3180 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-3180 | 70518-3180-0 | 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 |
|---|---|---|---|---|---|---|---|
| A077869-001 | ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | |
| A077869-002 | ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | |
| A077869-003 | ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077869-001 | AB |
| A077869-002 | AB |
| A077869-003 | 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 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077869-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | AB | 2006-05-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077869-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | AB | 2006-05-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077869-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | AB | 2006-05-31 | 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 | A077869-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077869-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077869-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077869-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077869-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077869-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077869-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077869-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077869-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077869-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077869-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077869-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077869-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077869-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077869-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077869-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077869-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077869-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077869-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077869-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077869-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077869-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077869-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077869-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077869-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077869-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077869-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077869-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077869-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077869-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077869-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077869-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077869-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077869-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077869-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077869-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077869-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077869-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077869-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077869-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-3180-0 | 2023-02-13 | C162847 | 48780-1 | f386c649-c8c3-0266-e053-dadaa90a7c1a | 09854775-55db-446c-a06e-d883563199e8 |
| 70518-3180-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c8c3-0266-e053-dadaa90a7c1a | 09854775-55db-446c-a06e-d883563199e8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3180 | ZONISAMIDE CAPSULE [REMEDYREPACK INC.] | 3 | Legacy NDC | 20240315_09854775-55db-446c-a06e-d883563199e8.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 |
|---|---|---|---|---|---|---|
| zonisamide | ZONISAMIDE | Cipla USA Inc. | e8f368cb-6a07-4178-95fa-1d5a209171ed | 2026-07-27 | Warnings, Adverse reactions | 077869 ANDA077869 |
| Zonisamide | ZONISAMIDE | AvPAK | b20a51ef-255e-1eb0-c0e1-461cde46b887 | 2025-10-21 | Warnings, Adverse reactions | 077869 ANDA077869 |
| zonisamide | ZONISAMIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 226d917a-33de-48cc-baf6-bd6a20668341 | 2024-10-23 | Warnings, Adverse reactions | 077869 ANDA077869 |
| Zonisamide | ZONISAMIDE | American Health Packaging | 7cdd96c4-3263-4c28-86c0-3c24bcef16c1 | 2024-05-30 | Warnings, Adverse reactions | 077869 ANDA077869 |
| zonisamide | ZONISAMIDE | Bryant Ranch Prepack | 64bd9d6f-8cc0-4151-a78d-9f1437b36875 | 2023-10-24 | Warnings, Adverse reactions | 077869 ANDA077869 |
| Zonisamide | ZONISAMIDE | Exelan Pharmaceuticals, Inc. | 24284954-0c29-458f-a9f8-97a7ad418ca7 | 2021-07-06 | Warnings, Adverse reactions | 077869 ANDA077869 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3180-0 | 70518318000 | 100 POUCH in 1 BOX (70518-3180-0) > 1 CAPSULE in 1 POUCH (70518-3180-1) | 100 pouch | 2021-08-04 | 0000-00-00 | No | No | Current |