Prescription drug · ANDA
Zonisamide NDC 63629-3293
Zonisamide 100 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3293-1 | 63629329301 | 100 CAPSULE in 1 BOTTLE (63629-3293-1)Marketed from Apr 13, 2010 | |
| 63629-3293-2 | 63629329302 | 90 CAPSULE in 1 BOTTLE (63629-3293-2)Marketed from Nov 18, 2008 | |
| 63629-3293-3 | 63629329303 | 30 CAPSULE in 1 BOTTLE (63629-3293-3)Marketed from Mar 29, 2013 | |
| 63629-3293-4 | 63629329304 | 60 CAPSULE in 1 BOTTLE (63629-3293-4)Marketed from Nov 10, 2011 | |
| 63629-3293-5 | 63629329305 | 120 CAPSULE in 1 BOTTLE (63629-3293-5)Marketed from May 31, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077634
- 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 63629-3293_c0015d1c-e43c-4870-8a67-b001736833e4SPL ID c0015d1c-e43c-4870-8a67-b001736833e4SPL set ID 6690c2cf-1634-93c0-7b2e-0ad4ca70cd6dRxCUI 314285UNII 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
N463629329301followed by a unit qualifier and the quantityPackage 63629-3293-01. 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 is 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 077634
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 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0962 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7438 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-260 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-258 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-259 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-897 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Direct_Rx | 72189-374 |