NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4349Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4349Add 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
70518-4349-070518434900100 POUCH in 1 BOX (70518-4349-0) / 1 CAPSULE in 1 POUCH (70518-4349-1)Marketed from May 30, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077645
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 70518-4349_5afa5342-1bf4-3c4c-e063-6394a90a86abSPL ID 5afa5342-1bf4-3c4c-e063-6394a90a86abSPL set ID 994e3ce0-f30b-47b1-aa42-b1ed37fb7c12RxCUI 403967UNII 459384H98V
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

N470518434900 followed by a unit qualifier and the quantity

Package 70518-4349-00. 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 USP 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 70518-4349

What is NDC 70518-4349?
70518-4349 is the product NDC for Zonisamide, Zonisamide 50 mg/1 capsule, listed with the FDA by REMEDYREPACK 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 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
ZonisamideZonisamide 100 mg/1CapsuleOralPreferred Pharmaceuticals Inc68788-400468788-4004-06

All 48 Zonisamide NDCs

Other NDCs under ANDA 077645

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

FDA NDC Directory listings under ANDA 077645
ProductStrengthForm · routeLabelerProduct NDC
ZonisamideZonisamide 100 mg/1CapsuleOralAurobindo Pharma Limited59651-380
ZonisamideZonisamide 25 mg/1CapsuleOralAurobindo Pharma Limited59651-378
ZonisamideZonisamide 50 mg/1CapsuleOralAurobindo Pharma Limited59651-379
ZonisamideZonisamide 100 mg/1CapsuleOralREMEDYREPACK INC.70518-3224

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