Prescription drug · ANDA
Zonisamide NDC 68462-128
Zonisamide 25 mg/1 · Capsule · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-128-01 | 68462012801 | 100 CAPSULE in 1 BOTTLE (68462-128-01)Marketed from Jan 30, 2006 | |
| 68462-128-05 | 68462012805 | 500 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
N468462012801followed by a unit qualifier and the quantityPackage 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.
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.
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 Pharmacy of Tennessee, LLC | 80425-0392 | 80425-0392-0180425-0392-02 |
| 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 25 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-040 | 72578-0040-0172578-0040-05 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-041 | 72578-0041-0172578-0041-05 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-042 | 72578-0042-0172578-0042-0572578-0042-10 |
Other NDCs under ANDA 077651
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 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4600 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-583 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2798 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-129 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-130 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-242 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-243 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-244 |