Zonisamide
- Product NDC
- 68788-4004
- 11-digit product format
- 687884004
- Labeler code
- 68788
- Product ID
- 68788-4004_061fdccc-d08e-4e42-8a32-54afb6c89701
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc
- Application
- ANDA077625
- Marketing category
- ANDA
- Marketing start
- 2022-07-04
- 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 |
|---|
| 68788-4004-6 | Zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4004-6 | 68788400406 | 60 CAPSULE in 1 BOTTLE (68788-4004-6) | 60 capsule | 2025-08-01 | No | No | Historical |