Zonisamide
- Product NDC
- 63629-3293
- 11-digit product format
- 636293293
- Labeler code
- 63629
- Product ID
- 63629-3293_39303fe6-8d9f-4fa1-91fa-4b012e71d6cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077634
- Marketing category
- ANDA
- Marketing start
- 2006-03-17
- Substance
- ZONISAMIDE
- Active strength
- 100 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zonisamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZONISAMIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 459384H98V |
| Rxcui | 314285 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-3293-1 | 2022-01-04 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-2 | 2022-01-04 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-3 | 2022-01-04 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-4 | 2022-01-04 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-5 | 2022-01-04 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-2 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-3 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-4 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
| 63629-3293-5 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4c2c-60a7-e053-dbdaa90a05bd | Zonisamide Capsules, for oral administration Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-3293-1 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 63629-3293-2 | Zonisamide | 90 in 1 BOTTLE | CAPSULE | 90 | | 5 |
| 63629-3293-3 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 63629-3293-4 | Zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
| 63629-3293-5 | Zonisamide | 120 in 1 BOTTLE | CAPSULE | 120 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-3293 | ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 5 package rows | 20231025_6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-3293-1 | 63629329301 | 100 CAPSULE in 1 BOTTLE (63629-3293-1) | 100 capsule | 2010-04-13 | 0000-00-00 | No | No | Current |
| 63629-3293-2 | 63629329302 | 90 CAPSULE in 1 BOTTLE (63629-3293-2) | 90 capsule | 2008-11-18 | 0000-00-00 | No | No | Current |
| 63629-3293-3 | 63629329303 | 30 CAPSULE in 1 BOTTLE (63629-3293-3) | 30 capsule | 2013-03-29 | 0000-00-00 | No | No | Current |
| 63629-3293-4 | 63629329304 | 60 CAPSULE in 1 BOTTLE (63629-3293-4) | 60 capsule | 2011-11-10 | 0000-00-00 | No | No | Current |
| 63629-3293-5 | 63629329305 | 120 CAPSULE in 1 BOTTLE (63629-3293-5) | 120 capsule | 2013-05-31 | 0000-00-00 | No | No | Current |