zonisamide
- Product NDC
- 53217-301
- 11-digit product format
- 532170301
- Labeler code
- 53217
- Product ID
- 53217-301_325e0a60-3a47-422a-a504-b445a426a2c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA077869
- Marketing category
- ANDA
- Marketing start
- 2016-07-13
- Marketing end
- 0000-00-00
- Substance
- ZONISAMIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-301-60 | zonisamide | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 53217-301-90 | zonisamide | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-301 | ZONISAMIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 2 package rows | 20170630_66c509ab-ecf3-48ff-bb6d-97989f3b747b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-301-60 | 53217030160 | 60 in 1 BOTTLE | Historical |
| 53217-301-90 | 53217030190 | 90 in 1 BOTTLE | Historical |