NDC codes

FDA NDC Directory
Product NDC (as listed)52652-8001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52652-8001Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
52652-8001-1526528001011 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

N452652800101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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