Prescription drug · ANDA
Zonisamide NDC 70771-1144
Zonisamide 100 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1144-0 | 7077111440070771114400 | 1000 CAPSULE in 1 BOTTLE (70771-1144-0)Marketed from Nov 22, 2017 | |
| 70771-1144-1 | 7077111440170771114401 | 100 CAPSULE in 1 BOTTLE (70771-1144-1)Marketed from Nov 22, 2017 | |
| 70771-1144-5 | 7077111440570771114405 | 500 CAPSULE in 1 BOTTLE (70771-1144-5)Marketed from Nov 22, 2017 |
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
- Zydus Lifesciences LimitedNDC labeler code 70771
- 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 70771-1144_1442d938-61eb-438e-b5be-900bda532050SPL ID 1442d938-61eb-438e-b5be-900bda532050
- 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
N470771114400followed by a unit qualifier and the quantityPackage 70771-1144-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70771-1144
- What is NDC 70771-1144?
- 70771-1144 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 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 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 |
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 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 |
| Zonisamide | Zonisamide 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0392 |