Zonisamide
- Product NDC
- 29300-428
- 11-digit product format
- 293000428
- Labeler code
- 29300
- Product ID
- 29300-428_337bce43-76dd-4e1c-bd1d-fcfc078baf0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA214492
- Marketing category
- ANDA
- Marketing start
- 2021-07-09
- 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 | 314285, 403966, 403967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-428-01 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 29300-428-05 | Zonisamide | 500 in 1 BOTTLE | CAPSULE | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-428 | ZONISAMIDE CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221201_3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 29300-428-01 | 29300042801 | 100 CAPSULE in 1 BOTTLE (29300-428-01) | 100 capsule | 2021-07-09 | 0000-00-00 | No | No | Current |
| 29300-428-05 | 29300042805 | 500 CAPSULE in 1 BOTTLE (29300-428-05) | 500 capsule | 2021-07-09 | 0000-00-00 | No | No | Current |