Prescription drug · ANDA
Zonisamide NDC 63187-897
Zonisamide 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-897-30 | 63187089730 | 30 CAPSULE in 1 BOTTLE (63187-897-30)Marketed from Aug 1, 2017 | |
| 63187-897-60 | 63187089760 | 60 CAPSULE in 1 BOTTLE (63187-897-60)Marketed from Aug 1, 2017 | |
| 63187-897-90 | 63187089790 | 90 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
N463187089730followed by a unit qualifier and the quantityPackage 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.
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.
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 077634
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 | Direct_Rx | 72189-374 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-3293 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0962 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7438 |
| Zonisamide | Zonisamide 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-259 |
| Zonisamide | Zonisamide 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-258 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-260 |