NDC codes

FDA NDC Directory
Product NDC (as listed)68001-243Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0243Add 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
68001-243-0068001024300100 CAPSULE in 1 BOTTLE (68001-243-00)Marketed from Mar 13, 2014

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
BluePoint LaboratoriesNDC labeler code 68001
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 68001-243_4c366d7a-f281-bb5b-e063-6294a90a7b60SPL ID 4c366d7a-f281-bb5b-e063-6294a90a7b60SPL set ID 345efcc4-6a36-4ddf-8b6c-9c6c844dab0aRxCUI 314285, 403966, 403967UNII 459384H98VUPC 0368001243001, 0368001244008
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

N468001024300 followed by a unit qualifier and the quantity

Package 68001-0243-00. 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 68001-243

What is NDC 68001-243?
68001-243 is the product NDC for Zonisamide, Zonisamide 50 mg/1 capsule, listed with the FDA by BluePoint Laboratories. 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?
BluePoint Laboratories, NDC labeler code 68001. 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 25 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-128
ZonisamideZonisamide 100 mg/1CapsuleOralGlenmark Pharmaceuticals Inc., USA68462-130
ZonisamideZonisamide 25 mg/1CapsuleOralBluePoint Laboratories68001-242
ZonisamideZonisamide 100 mg/1CapsuleOralBluePoint Laboratories68001-244

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