Zonisamide
- Product NDC
- 70518-4600
- 11-digit product format
- 705184600
- Labeler code
- 70518
- Product ID
- 70518-4600_4e64df76-2a67-31fd-e063-6294a90ab018
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077651
- Marketing category
- ANDA
- Marketing start
- 2026-03-31
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zonisamide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZONISAMIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 459384H98V |
| Rxcui | 403966 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4600-0 | Zonisamide | 100 in 1 BOX | CAPSULE | 100 | | 2 |
| 70518-4600-1 | Zonisamide | 1 in 1 POUCH | CAPSULE | 1 | | 2 |
| 70518-4600-2 | Zonisamide | 50 in 1 BOX | CAPSULE | 50 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4600-0 | 70518460000 | 100 POUCH in 1 BOX (70518-4600-0) / 1 CAPSULE in 1 POUCH (70518-4600-1) | 100 pouch | 2026-03-31 | No | No | Current |
| 70518-4600-1 | 70518460001 | 1 in 1 POUCH | | | | | Historical |
| 70518-4600-2 | 70518460002 | 50 POUCH in 1 BOX (70518-4600-2) / 1 CAPSULE in 1 POUCH (70518-4600-1) | 50 pouch | 2026-05-27 | 0 | | Current |