Prescription drug · ANDA
Rizatriptan Benzoate NDC 69097-865
Rizatriptan benzoate 5 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-865-17 | 69097086517 | 6 TABLET in 1 BLISTER PACK (69097-865-17)Marketed from Jul 22, 2016 | |
| 69097-865-85 | 69097086585 | 3 TABLET in 1 CARTON (69097-865-85)Marketed from Jul 22, 2016 |
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)
- Rizatriptan Benzoate
- Generic name (nonproprietary)
- rizatriptan benzoate
- Active ingredients
- Rizatriptan benzoate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204339
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69097-865_6ace7fac-e700-4a32-95ce-07ffbd0201eaSPL ID 6ace7fac-e700-4a32-95ce-07ffbd0201eaSPL set ID f462a507-921c-41c2-93ba-36003b6e8914RxCUI 312840, 314209UNII WR978S7QHH
- 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
N469097086517followed by a unit qualifier and the quantityPackage 69097-0865-17. 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)
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use : Use only after clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1) Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a pati…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204339
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 |
|---|---|---|---|---|
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | TabletOral | DIRECT RX | 61919-394 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-866 |