NDC codes

FDA NDC Directory
Product NDC (as listed)63187-897Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0897Add 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
63187-897-306318708973030 CAPSULE in 1 BOTTLE (63187-897-30)Marketed from Aug 1, 2017
63187-897-606318708976060 CAPSULE in 1 BOTTLE (63187-897-60)Marketed from Aug 1, 2017
63187-897-906318708979090 CAPSULE in 1 BOTTLE (63187-897-90)Marketed from Aug 1, 2017

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
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077634
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 63187-897_07dda324-2d2e-489f-ab71-004579ac5eceSPL ID 07dda324-2d2e-489f-ab71-004579ac5eceSPL set ID 812582ce-fc7e-44b1-a428-7faa3701c1b8RxCUI 314285UNII 459384H98VUPC 0363187897307
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

N463187089730 followed by a unit qualifier and the quantity

Package 63187-0897-30. 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 is 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 63187-897

What is NDC 63187-897?
63187-897 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 63187. 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 077634

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

FDA NDC Directory listings under ANDA 077634
ProductStrengthForm · routeLabelerProduct NDC
ZonisamideZonisamide 25 mg/1CapsuleOralDirect_Rx72189-374
ZonisamideZonisamide 100 mg/1CapsuleOralBryant Ranch Prepack63629-3293
ZonisamideZonisamide 50 mg/1CapsuleOralBryant Ranch Prepack71335-0962
ZonisamideZonisamide 100 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7438
ZonisamideZonisamide 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.62756-259
ZonisamideZonisamide 25 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.62756-258
ZonisamideZonisamide 100 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.62756-260

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