Prescription drug · ANDA
Zolmitriptan NDC 72189-435
Zolmitriptan 5 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-435-03 | 72189043503 | 3 TABLET in 1 BOTTLE (72189-435-03)Marketed from Mar 13, 2023 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204041
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72189-435_2c4d7edc-6dd1-357b-e063-6294a90a298cSPL ID 2c4d7edc-6dd1-357b-e063-6294a90a298cSPL set ID f6ca22bf-caf1-89af-e053-6394a90a2987RxCUI 200194UNII 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
N472189043503followed by a unit qualifier and the quantityPackage 72189-0435-03. 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 tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204041
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 | TabletOral | Direct_Rx | 72189-434 |
| Zolmitriptan | Zolmitriptan 2.5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-336 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-337 |
| Zolmitriptan | Zolmitriptan 2.5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-021 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-022 |