Zonisamide
- Product NDC
- 59651-380
- 11-digit product format
- 596510380
- Labeler code
- 59651
- Product ID
- 59651-380_b43ac632-68f3-43f6-aa79-41429a54e1ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077645
- Marketing category
- ANDA
- Marketing start
- 2020-08-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zonisamide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZONISAMIDE | 100 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 |
|---|
| 59651-380-01 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
| 59651-380-03 | Zonisamide | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
| 59651-380-05 | Zonisamide | 500 in 1 BOTTLE | CAPSULE | 500 | | 6 |
| 59651-380-60 | Zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-380 | ZONISAMIDE CAPSULE [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 4 package rows | 20231007_ab0631ca-5339-4570-bc27-f1dd92de1d6f.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 |
|---|
| 59651-380-01 | 59651038001 | 100 CAPSULE in 1 BOTTLE (59651-380-01) | 100 capsule | 2020-08-17 | 0000-00-00 | No | No | Current |
| 59651-380-03 | 59651038003 | 30 CAPSULE in 1 BOTTLE (59651-380-03) | 30 capsule | 2020-08-17 | 0000-00-00 | No | No | Current |
| 59651-380-05 | 59651038005 | 500 CAPSULE in 1 BOTTLE (59651-380-05) | 500 capsule | 2020-08-17 | 0000-00-00 | No | No | Current |
| 59651-380-60 | 59651038060 | 60 CAPSULE in 1 BOTTLE (59651-380-60) | 60 capsule | 2020-08-17 | 0000-00-00 | No | No | Current |
| 59651-380-82 | 59651038082 | 800 CAPSULE in 1 BAG (59651-380-82) | 800 capsule | 17-AUG-20 | | | | Current |