Zonisamide
- Product NDC
- 72578-040
- 11-digit product format
- 725780040
- Labeler code
- 72578
- Product ID
- 72578-040_ae95556a-06c3-4e0e-9b9e-562ae444579c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA077625
- Marketing category
- ANDA
- Marketing start
- 2022-07-04
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zonisamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZONISAMIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 459384H98V |
| Rxcui | 314285, 403966, 403967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72578-040-01 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 72578-040-05 | Zonisamide | 500 in 1 BOTTLE | CAPSULE | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-040 | ZONISAMIDE CAPSULE [VIONA PHARMACEUTICALS INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231121_5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e.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 |
|---|
| 72578-040-01 | 72578004001 | 100 CAPSULE in 1 BOTTLE (72578-040-01) | 100 capsule | 2022-07-04 | 0000-00-00 | No | No | Current |
| 72578-040-05 | 72578004005 | 500 CAPSULE in 1 BOTTLE (72578-040-05) | 500 capsule | 2022-07-04 | 0000-00-00 | No | No | Current |