Zonisamide
- Product NDC
- 70518-3903
- 11-digit product format
- 705183903
- Labeler code
- 70518
- Product ID
- 70518-3903_3b9ebc30-0b49-baf9-e063-6294a90a7b38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077625
- Marketing category
- ANDA
- Marketing start
- 2023-10-24
- 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 |
|---|
| 70518-3903-0 | Zonisamide | 100 in 1 BOX | CAPSULE | 100 | | 4 |
| 70518-3903-1 | Zonisamide | 1 in 1 POUCH | CAPSULE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3903 | ZONISAMIDE CAPSULE [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20240404_40094d96-e979-4b3e-840f-a96677480f96.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 |
|---|
| 70518-3903-0 | 70518390300 | 100 POUCH in 1 BOX (70518-3903-0) / 1 CAPSULE in 1 POUCH (70518-3903-1) | 100 pouch | 2023-10-24 | No | No | Current |
| 70518-3903-1 | 70518390301 | 1 in 1 POUCH | | | | | Historical |