Prescription drug · NDA
Zonegran (Zonisamide) NDC 59212-681
Zonisamide 25 mg/1 · Capsule · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-681-10 | 59212068110 | 100 CAPSULE in 1 BOTTLE (59212-681-10)Marketed from Mar 27, 2000 |
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)
- Zonegran
- Generic name (nonproprietary)
- zonisamide
- Active ingredients
- Zonisamide — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.NDC labeler code 59212
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020789
- 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 59212-681_66904ccc-bcd1-427c-95ed-bfa633bbf0b2SPL ID 66904ccc-bcd1-427c-95ed-bfa633bbf0b2
- 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
N459212068110followed by a unit qualifier and the quantityPackage 59212-0681-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 59212-681
- What is NDC 59212-681?
- 59212-681 is the product NDC for Zonegran (zonisamide), Zonisamide 25 mg/1 capsule, listed with the FDA by Advanz Pharma (US) Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zonegran (Zonisamide).
- What is the active ingredient?
- Zonisamide.
- Who is the labeler?
- Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zonegran?
- 1 other product NDC are listed under this name. See all Zonegran NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zonegran products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zonegranzonisamide | Zonisamide 100 mg/1 | CapsuleOral | Advanz Pharma (US) Corp. | 59212-680 | 59212-0680-10 |
Other NDCs under NDA 020789
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 |
|---|---|---|---|---|
| Zonegranzonisamide | Zonisamide 100 mg/1 | CapsuleOral | Advanz Pharma (US) Corp. | 59212-680 |