Prescription drug · ANDA
Zonisamide NDC 80425-0392
Zonisamide 100 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0392-1 | 8042503920180425039201 | 30 CAPSULE in 1 BOTTLE (80425-0392-1)Marketed from May 23, 2024 | |
| 80425-0392-2 | 8042503920280425039202 | 60 CAPSULE in 1 BOTTLE (80425-0392-2)Marketed from May 23, 2024 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077625
- 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 80425-0392_19b070b3-73b3-4f4a-e063-6294a90af594SPL ID 19b070b3-73b3-4f4a-e063-6294a90af594SPL set ID 19b059f0-a08a-f75a-e063-6294a90a57dbRxCUI 314285UNII 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
N480425039201followed by a unit qualifier and the quantityPackage 80425-0392-01. 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.
About NDC 80425-0392
- What is NDC 80425-0392?
- 80425-0392 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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.
Related NDCs: other Zonisamide products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 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 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-040 | 72578-0040-0172578-0040-05 |
Other NDCs under ANDA 077625
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc | 68788-4004 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3903 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1142 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1143 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1144 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2796 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2797 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Direct_Rx | 72189-624 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-040 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-041 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-042 |