Prescription drug · ANDA
Zonisamide NDC 72578-041
Zonisamide 50 mg/1 · Capsule · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-041-01 | 72578004101 | 100 CAPSULE in 1 BOTTLE (72578-041-01)Marketed from Jul 4, 2022 | |
| 72578-041-05 | 72578004105 | 500 CAPSULE in 1 BOTTLE (72578-041-05)Marketed from Jul 4, 2022 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077625
- 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 72578-041_ae95556a-06c3-4e0e-9b9e-562ae444579cSPL ID ae95556a-06c3-4e0e-9b9e-562ae444579cSPL set ID 5ab5b6aa-4bdc-4ec6-ba23-44caf2db953eRxCUI 314285, 403966, 403967UNII 459384H98V
- 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
N472578004101followed by a unit qualifier and the quantityPackage 72578-0041-01. 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 077625
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 25 mg/1 | CapsuleOral | Direct_Rx | 72189-624 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-040 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-042 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1142 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc | 68788-4004 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1143 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1144 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3903 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0392 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2796 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2797 |