Zonisamide
- Product NDC
- 68788-7438
- 11-digit product format
- 687887438
- Labeler code
- 68788
- Product ID
- 68788-7438_f89c358d-7cac-47a8-896e-5580c38b102e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7438-1 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 68788-7438-3 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
| 68788-7438-6 | Zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 7 |
| 68788-7438-9 | Zonisamide | 90 in 1 BOTTLE | CAPSULE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7438 | ZONISAMIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240907_53ecba6c-0de4-4e11-81d5-6deac79accd5.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 |
|---|
| 68788-7438-1 | 68788743801 | 100 CAPSULE in 1 BOTTLE (68788-7438-1) | 100 capsule | 2019-12-26 | 0000-00-00 | No | No | Current |
| 68788-7438-3 | 68788743803 | 30 CAPSULE in 1 BOTTLE (68788-7438-3) | 30 capsule | 2019-12-26 | 0000-00-00 | No | No | Current |
| 68788-7438-6 | 68788743806 | 60 CAPSULE in 1 BOTTLE (68788-7438-6) | 60 capsule | 2019-12-26 | 0000-00-00 | No | No | Current |
| 68788-7438-9 | 68788743809 | 90 CAPSULE in 1 BOTTLE (68788-7438-9) | 90 capsule | 2019-12-26 | 0000-00-00 | No | No | Current |