What is NDC 76282-227?

76282-227 is the product NDC for Zonisamide, Zonisamide 50 mg/1 capsule, listed with the FDA by Exelan Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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?

47 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 76282-227 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-227Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0227Add 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
76282-227-01	7628202270176282022701	100 CAPSULE in 1 BOTTLE (76282-227-01)Marketed from Mar 15, 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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Exelan Pharmaceuticals, Inc.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077869
Marketing start: Mar 15, 2021
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 76282-227_5b700833-52ca-46ef-8874-67b56595db24SPL ID 5b700833-52ca-46ef-8874-67b56595db24SPL set ID 24284954-0c29-458f-a9f8-97a7ad418ca7RxCUI 314285, 403966, 403967UNII 459384H98VUPC 0376282228013, 0376282226019, 0376282227016
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

N476282022701 followed by a unit qualifier and the quantity

Package 76282-0227-01. 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 Jul 6, 2021.

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 76282-227

What is NDC 76282-227?: 76282-227 is the product NDC for Zonisamide, Zonisamide 50 mg/1 capsule, listed with the FDA by Exelan Pharmaceuticals, Inc.. 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?: Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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?: 47 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	Bryant Ranch Prepack	71335-2797	71335-2797-0171335-2797-0271335-2797-03+2 more
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	Preferred Pharmaceuticals Inc	68788-4004	68788-4004-06

All 48 Zonisamide NDCs

Other NDCs under ANDA 077869

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

FDA NDC Directory listings under ANDA 077869
Product	Strength	Form · route	Labeler	Product NDC
zonisamide	Zonisamide 100 mg/1	CapsuleOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8266
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	AvPAK	50268-816
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	American Health Packaging	60687-230
zonisamide	Zonisamide 100 mg/1	CapsuleOral	Cipla USA Inc.	69097-861
zonisamide	Zonisamide 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0486
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Exelan Pharmaceuticals, Inc.	76282-226
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Exelan Pharmaceuticals, Inc.	76282-228