Prescription drug · NDA
Zonisade (Zonisamide) NDC 52652-8001
Zonisamide 100 mg/5mL · Suspension · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52652-8001-1 | 52652800101 | 1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLEMarketed from Jul 15, 2022 |
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)
- Zonisade
- Generic name (nonproprietary)
- zonisamide
- Active ingredients
- Zonisamide — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 52652
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214273
- 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 52652-8001_063fd04f-90bf-4b1f-99fe-4e2cdb5b1eeaSPL ID 063fd04f-90bf-4b1f-99fe-4e2cdb5b1eeaSPL set ID ac16fa15-32e9-4f92-8bc6-d8d41ae002c6RxCUI 2606782, 2606788UNII 459384H98VUPC 0352652800119
- 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
N452652800101followed by a unit qualifier and the quantityPackage 52652-8001-01. 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)
ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years and older. ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 52652-8001
- What is NDC 52652-8001?
- 52652-8001 is the product NDC for Zonisade (zonisamide), Zonisamide 100 mg/5mL suspension, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zonisade (Zonisamide).
- What is the active ingredient?
- Zonisamide.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 52652. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zonisade?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.