What is NDC 72578-042?

72578-042 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Viona Pharmaceuticals Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 72578-042 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-042Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0042Add 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
72578-042-01	7257800420172578004201	100 CAPSULE in 1 BOTTLE (72578-042-01)Marketed from Jul 4, 2022
72578-042-05	7257800420572578004205	500 CAPSULE in 1 BOTTLE (72578-042-05)Marketed from Jul 4, 2022
72578-042-10	7257800421072578004210	1000 CAPSULE in 1 BOTTLE (72578-042-10)Marketed from Jul 4, 2022

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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077625
Marketing start: Jul 4, 2022
Listing expires: Dec 31, 2027
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 72578-042_01fdcace-12a4-44bc-9962-ea4c79395f84SPL ID 01fdcace-12a4-44bc-9962-ea4c79395f84
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

N472578004201 followed by a unit qualifier and the quantity

Package 72578-0042-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 72578-042

What is NDC 72578-042?: 72578-042 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Viona Pharmaceuticals Inc. It has 3 package NDCs, 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?: Viona Pharmaceuticals Inc, NDC labeler code 72578. 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	Advanced Rx of Tennessee, LLC	80425-0370	80425-0370-01
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

All 46 Zonisamide NDCs

Other NDCs under ANDA 077625

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

FDA NDC Directory listings under ANDA 077625
Product	Strength	Form · route	Labeler	Product NDC
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc	68788-4004
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3903
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1142
Zonisamide	Zonisamide 50 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1143
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1144
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2796
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2797
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Direct_Rx	72189-624
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-040
Zonisamide	Zonisamide 50 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-041
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0392