Zonisamide
- Product NDC
- 68382-213
- 11-digit product format
- 683820213
- Labeler code
- 68382
- Product ID
- 68382-213_61639a39-ae22-47e9-9bc0-97fb0c5c2c2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA077625
- Marketing category
- ANDA
- Marketing start
- 2017-11-22
- Marketing end
- 0000-00-00
- Substance
- ZONISAMIDE
- Active strength
- 50 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-213-01 | 68382021301 | 100 CAPSULE in 1 BOTTLE (68382-213-01) | 100 capsule | 2017-11-22 | 0000-00-00 | No | No | Current |
| 68382-213-05 | 68382021305 | 500 CAPSULE in 1 BOTTLE (68382-213-05) | 500 capsule | 2017-11-22 | 0000-00-00 | No | No | Current |