Zonisamide
- Product NDC
- 62756-258
- 11-digit product format
- 627560258
- Labeler code
- 62756
- Product ID
- 62756-258_d0c9002b-fa32-4ca8-862f-5286746df2cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077634
- Marketing category
- ANDA
- Marketing start
- 2006-03-17
- 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 |
|---|
| 62756-258-01 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 10 |
| 62756-258-02 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 62756-258-03 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 62756-258-04 | Zonisamide | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-258 | ZONISAMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20200818_3164d438-90bf-420a-9a56-5498b987f91c.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 |
|---|
| 62756-258-01 | 62756025801 | 30 CAPSULE in 1 BOTTLE (62756-258-01) | 30 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |
| 62756-258-02 | 62756025802 | 100 CAPSULE in 1 BOTTLE (62756-258-02) | 100 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |
| 62756-258-03 | 62756025803 | 100 CAPSULE in 1 BOTTLE (62756-258-03) | 100 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |
| 62756-258-04 | 62756025804 | 1000 CAPSULE in 1 BOTTLE (62756-258-04) | 1000 capsule | 2006-03-17 | 0000-00-00 | No | No | Current |