Zonisamide
- Product NDC
- 63187-583
- 11-digit product format
- 631870583
- Labeler code
- 63187
- Product ID
- 63187-583_81a1a2d9-e7d9-4738-9d4d-fd70c9e4618f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077651
- Marketing category
- ANDA
- Marketing start
- 2006-01-30
- 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 |
|---|
| 63187-583-30 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
| 63187-583-60 | Zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 4 |
| 63187-583-90 | Zonisamide | 90 in 1 BOTTLE | CAPSULE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-583 | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20221021_85321a9a-08d9-49e4-8c79-86ecfc536613.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 |
|---|
| 63187-583-30 | 63187058330 | 30 CAPSULE in 1 BOTTLE (63187-583-30) | 30 capsule | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-583-60 | 63187058360 | 60 CAPSULE in 1 BOTTLE (63187-583-60) | 60 capsule | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-583-90 | 63187058390 | 90 CAPSULE in 1 BOTTLE (63187-583-90) | 90 capsule | 2018-12-01 | 0000-00-00 | No | No | Current |