What is NDC 69097-861?

69097-861 is the product NDC for zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-861 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-861Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0861Add 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
69097-861-07	6909708610769097086107	100 CAPSULE in 1 BOTTLE (69097-861-07)Marketed from Jul 13, 2016
69097-861-12	6909708611269097086112	500 CAPSULE in 1 BOTTLE (69097-861-12)Marketed from Jul 13, 2016

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: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077869
Marketing start: Jul 13, 2016
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 69097-861_afd3742a-070e-48e7-aa6a-6cc534552687SPL ID afd3742a-070e-48e7-aa6a-6cc534552687SPL set ID e8f368cb-6a07-4178-95fa-1d5a209171edRxCUI 314285UNII 459384H98VUPC 0369097861070
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

N469097086107 followed by a unit qualifier and the quantity

Package 69097-0861-07. 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 27, 2026.

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 69097-861

What is NDC 69097-861?: 69097-861 is the product NDC for zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 2 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?: Cipla USA Inc., NDC labeler code 69097. 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 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	Bryant Ranch Prepack	71335-0486
Zonisamide	Zonisamide 25 mg/1	CapsuleOral	Exelan Pharmaceuticals, Inc.	76282-226
Zonisamide	Zonisamide 50 mg/1	CapsuleOral	Exelan Pharmaceuticals, Inc.	76282-227
Zonisamide	Zonisamide 100 mg/1	CapsuleOral	Exelan Pharmaceuticals, Inc.	76282-228