Zonisamide
- Product NDC
- 80425-0392
- 11-digit product format
- 804250392
- Labeler code
- 80425
- Product ID
- 80425-0392_19b070b3-73b3-4f4a-e063-6294a90af594
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA077625
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- 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 |
|---|
| 80425-0392-1 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 80425-0392-2 | Zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0392 | ZONISAMIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20240601_19b059f0-a08a-f75a-e063-6294a90a57db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0392-1 | 80425039201 | 30 CAPSULE in 1 BOTTLE (80425-0392-1) | 30 capsule | 2024-05-23 | No | No | Historical |
| 80425-0392-2 | 80425039202 | 60 CAPSULE in 1 BOTTLE (80425-0392-2) | 60 capsule | 2024-05-23 | No | No | Historical |