Zonisamide NDC 29300-428

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-428Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0428Add 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 NDC	11-digit (billing)	Package	Copy
29300-428-01	29300042801	100 CAPSULE in 1 BOTTLE (29300-428-01)Marketed from Jul 9, 2021
29300-428-05	29300042805	500 CAPSULE in 1 BOTTLE (29300-428-05)Marketed from Jul 9, 2021

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 — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214492
Marketing start: Jul 9, 2021
Listing expires: Dec 31, 2026
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 29300-428_337bce43-76dd-4e1c-bd1d-fcfc078baf0bSPL ID 337bce43-76dd-4e1c-bd1d-fcfc078baf0bSPL set ID 3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0RxCUI 314285, 403966, 403967UNII 459384H98VUPC 0329300430011
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

N429300042801 followed by a unit qualifier and the quantity

Package 29300-0428-01. 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 Nov 30, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Zonisamide Capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214492

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214492
Product	Strength	Form · route	Labeler	Product NDC
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Proficient Rx LP	71205-727
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-9679
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0370
Zonisamide	Zonisamide 50 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-429
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-430