Zonisamide
- Product NDC
- 70518-4349
- 11-digit product format
- 705184349
- Labeler code
- 70518
- Product ID
- 70518-4349_365be0d1-cb8d-861b-e063-6294a90a9d8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077645
- Marketing category
- ANDA
- Marketing start
- 2025-05-30
- Substance
- ZONISAMIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 459384H98V |
| Rxcui | 403967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4349-0 | Zonisamide | 100 in 1 BOX | CAPSULE | 100 | | 1 |
| 70518-4349-1 | Zonisamide | 1 in 1 POUCH | CAPSULE | 1 | | 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 |
|---|
| 70518-4349-0 | 70518434900 | 100 POUCH in 1 BOX (70518-4349-0) / 1 CAPSULE in 1 POUCH (70518-4349-1) | 100 pouch | 2025-05-30 | No | No | Current |
| 70518-4349-1 | 70518434901 | 1 in 1 POUCH | | | | | Historical |