Prescription drug · ANDA
Zonisamide NDC 76282-226
Zonisamide 25 mg/1 · Capsule · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-226-01 | 76282022601 | 100 CAPSULE in 1 BOTTLE (76282-226-01)Marketed from Mar 15, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zonisamide
- Generic name (nonproprietary)
- zonisamide
- Active ingredients
- Zonisamide — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077869
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)P-Glycoprotein Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 76282-226_5b700833-52ca-46ef-8874-67b56595db24SPL ID 5b700833-52ca-46ef-8874-67b56595db24SPL set ID 24284954-0c29-458f-a9f8-97a7ad418ca7RxCUI 314285, 403966, 403967UNII 459384H98VUPC 0376282228013, 0376282226019, 0376282227016
- Pharmacologic class
- Anti-epileptic Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476282022601followed by a unit qualifier and the quantityPackage 76282-0226-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077869
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| zonisamide | Zonisamide 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8266 |
| zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0486 |
| zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-861 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | American Health Packaging | 60687-230 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-227 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-228 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | AvPAK | 50268-816 |