NDC codes

FDA NDC Directory
Product NDC (as listed)68462-128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0128Add 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 NDC11-digit (billing)PackageCopy
68462-128-0168462012801100 CAPSULE in 1 BOTTLE (68462-128-01)Marketed from Jan 30, 2006
68462-128-0568462012805500 CAPSULE in 1 BOTTLE (68462-128-05)Marketed from Jan 30, 2006

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
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077651
Marketing start
Listing expires
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 68462-128_c00ccc2d-52c6-4a11-a310-d8db25ca3928SPL ID c00ccc2d-52c6-4a11-a310-d8db25ca3928SPL set ID fe15e56e-8b86-4a65-825c-31d37dd81612RxCUI 314285, 403966, 403967UNII 459384H98VUPC 0368462130018, 0368462129012, 0368462128015
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

N468462012801 followed by a unit qualifier and the quantity

Package 68462-0128-01. 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 .

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 68462-128

What is NDC 68462-128?
68462-128 is the product NDC for Zonisamide, Zonisamide 25 mg/1 capsule, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ZonisamideZonisamide 25 mg/1CapsuleOralREMEDYREPACK INC.70518-460070518-4600-0070518-4600-02
ZonisamideZonisamide 50 mg/1CapsuleOralREMEDYREPACK INC.70518-434970518-4349-00
ZonisamideZonisamide 25 mg/1CapsuleOralDirect_Rx72189-62472189-0624-72
ZonisamideZonisamide 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-039280425-0392-0180425-0392-02
ZonisamideZonisamide 100 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-037080425-0370-01
ZonisamideZonisamide 100 mg/1CapsuleOralREMEDYREPACK INC.70518-390370518-3903-00
ZonisamideZonisamide 25 mg/1CapsuleOralDirect_Rx72189-37472189-0374-72
ZonisamideZonisamide 25 mg/1CapsuleOralViona Pharmaceuticals Inc72578-04072578-0040-0172578-0040-05
ZonisamideZonisamide 50 mg/1CapsuleOralViona Pharmaceuticals Inc72578-04172578-0041-0172578-0041-05
ZonisamideZonisamide 100 mg/1CapsuleOralViona Pharmaceuticals Inc72578-04272578-0042-0172578-0042-0572578-0042-10

All 48 Zonisamide NDCs

Other NDCs under ANDA 077651

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

FDA NDC Directory listings under ANDA 077651
ProductStrengthForm · routeLabelerProduct NDC
ZonisamideZonisamide 25 mg/1CapsuleOralREMEDYREPACK INC.70518-4600
ZonisamideZonisamide 100 mg/1CapsuleOralProficient Rx LP63187-583
ZonisamideZonisamide 25 mg/1CapsuleOralBryant Ranch Prepack71335-2798
ZonisamideZonisamide 50 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-129
ZonisamideZonisamide 100 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-130
ZonisamideZonisamide 25 mg/1CapsuleOralBluePoint Laboratories68001-242
ZonisamideZonisamide 50 mg/1CapsuleOralBluePoint Laboratories68001-243
ZonisamideZonisamide 100 mg/1CapsuleOralBluePoint Laboratories68001-244

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