Prescription drug · ANDA
Zonisamide NDC 59651-379
Zonisamide 50 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-379-01 | 59651037901 | 100 CAPSULE in 1 BOTTLE (59651-379-01)Marketed from Aug 17, 2020 | |
| 59651-379-03 | 59651037903 | 30 CAPSULE in 1 BOTTLE (59651-379-03)Marketed from Aug 17, 2020 | |
| 59651-379-05 | 59651037905 | 500 CAPSULE in 1 BOTTLE (59651-379-05)Marketed from Aug 17, 2020 | |
| 59651-379-60 | 59651037960 | 60 CAPSULE in 1 BOTTLE (59651-379-60)Marketed from Aug 17, 2020 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077645
- 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 59651-379_b43ac632-68f3-43f6-aa79-41429a54e1efSPL ID b43ac632-68f3-43f6-aa79-41429a54e1efSPL set ID ab0631ca-5339-4570-bc27-f1dd92de1d6fRxCUI 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
N459651037901followed by a unit qualifier and the quantityPackage 59651-0379-01. 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 USP are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Excerpt only. Read the full label for complete information.
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.