What is NDC 80425-0370?

80425-0370 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zonisamide?

45 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zonisamide NDC 80425-0370 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0370Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0370Add 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
80425-0370-1	8042503700180425037001	30 CAPSULE in 1 BOTTLE (80425-0370-1)Marketed from Dec 5, 2023

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: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214492
Marketing start: Dec 5, 2023
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 80425-0370_2a9968c3-c1b9-9ce1-e063-6294a90a8051SPL ID 2a9968c3-c1b9-9ce1-e063-6294a90a8051SPL set ID 0bc550a7-09a7-75e4-e063-6294a90a9fc1RxCUI 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

N480425037001 followed by a unit qualifier and the quantity

Package 80425-0370-01. 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 Dec 31, 2024.

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)

About NDC 80425-0370

What is NDC 80425-0370?: 80425-0370 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zonisamide.
What is the active ingredient?: Zonisamide.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zonisamide?: 45 other product NDCs are listed under this name. See all Zonisamide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zonisamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4600	70518-4600-0070518-4600-02
Zonisamide	Zonisamide 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4349	70518-4349-00
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Direct_Rx	72189-624	72189-0624-72
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0392	80425-0392-0180425-0392-02
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3903	70518-3903-00
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Direct_Rx	72189-374	72189-0374-72
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc	68788-4004	68788-4004-06
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2796	71335-2796-0171335-2796-0271335-2796-03+1 more
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2797	71335-2797-0171335-2797-0271335-2797-03+2 more
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-040	72578-0040-0172578-0040-05

All 46 Zonisamide NDCs

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 25 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-428
Zonisamide	Zonisamide 50 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-429
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-430
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Proficient Rx LP	71205-727
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-9679