Zonisamide
- Product NDC
- 71335-2796
- 11-digit product format
- 713352796
- Labeler code
- 71335
- Product ID
- 71335-2796_94aeaba7-6c30-45d2-9dce-0b4fd4f3feb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 | 403966 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2796-1 | 71335279601 | 60 CAPSULE in 1 BOTTLE (71335-2796-1) | 60 capsule | 2025-10-13 | No | No | Historical |
| 71335-2796-2 | 71335279602 | 90 CAPSULE in 1 BOTTLE (71335-2796-2) | 90 capsule | 2025-10-13 | No | No | Historical |
| 71335-2796-3 | 71335279603 | 30 CAPSULE in 1 BOTTLE (71335-2796-3) | 30 capsule | 2025-10-13 | No | No | Historical |
| 71335-2796-4 | 71335279604 | 70 CAPSULE in 1 BOTTLE (71335-2796-4) | 70 capsule | 2025-10-13 | No | No | Historical |