Prescription drug · ANDA
Zolmitriptan OD (zolmitriptan) NDC 59746-462
Zolmitriptan 5 mg/1 · Tablet, Orally disintegrating · Oral · Jubilant Cadista Pharmacuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59746-462-13 | 59746046213 | 1 BLISTER PACK in 1 CARTON (59746-462-13) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 17, 2015 |
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)
- Zolmitriptan OD
- Generic name (nonproprietary)
- zolmitriptan
- Active ingredients
- Zolmitriptan — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202956
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 59746-462_5d9c2d59-8564-44d8-bd79-0e0b34ec50bdSPL ID 5d9c2d59-8564-44d8-bd79-0e0b34ec50bdSPL set ID a6a32fc6-4243-9cdd-91c7-b8a58e0f9811RxCUI 284201, 351134UNII 2FS66TH3YWUPC 0359746462130, 0359746461164
- Pharmacologic class
- Serotonin-1b and Serotonin-1d Receptor Agonist
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
N459746046213followed by a unit qualifier and the quantityPackage 59746-0462-13. 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)
Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan orally disintegrating tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan orally disintegrating tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan orally disintegrating tablets are administered to treat any subsequent attacks. Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan orally disintegrating tablets have not been establishe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202956
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 |
|---|---|---|---|---|
| Zolmitriptan ODzolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-998 |
| Zolmitriptan ODzolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-999 |
| Zolmitriptan ODzolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Orally disintegratingOral | Jubilant Cadista Pharmacuticals Inc. | 59746-461 |