Prescription drug · ANDA
Zolmitriptan NDC 62332-181
Zolmitriptan 2.5 mg/1 · Tablet, Orally disintegrating · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-181-06 | 62332018106 | 1 BLISTER PACK in 1 CARTON (62332-181-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 10, 2024 |
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
- Generic name (nonproprietary)
- zolmitriptan
- Active ingredients
- Zolmitriptan — 2.5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205074
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62332-181_25dbf96f-b71d-447c-991a-2b9dc5971303SPL ID 25dbf96f-b71d-447c-991a-2b9dc5971303SPL set ID 89bfee8d-1ddf-4fb2-a565-ce32f096a25dRxCUI 284201, 351134UNII 2FS66TH3YW
- 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
N462332018106followed by a unit qualifier and the quantityPackage 62332-0181-06. 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 is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. Zolmitriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan have not been established for cluster headache. Zolmitriptan is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1) Limitation…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205074
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 | Zolmitriptan 2.5 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-181 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-182 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-182 |