Prescription drug · ANDA
Rizatriptan Benzoate NDC 29300-269
Rizatriptan benzoate 10 mg/1 · Tablet, Orally disintegrating · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-269-21 | 29300026921 | 4 BLISTER PACK in 1 CARTON (29300-269-21) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-269-31)Marketed from Jul 5, 2017 | |
| 29300-269-81 | 29300026981 | 6 BLISTER PACK in 1 CARTON (29300-269-81) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-269-31)Marketed from Jul 5, 2017 | |
| 29300-269-91 | 29300026991 | 3 BLISTER PACK in 1 CARTON (29300-269-91) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-269-31)Marketed from Jul 5, 2017 |
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 — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207835
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 29300-269_69ca309f-1132-40c9-b250-665c360968e3SPL ID 69ca309f-1132-40c9-b250-665c360968e3SPL set ID 3cdeccf6-36dd-4a9e-9687-2f7cce47af5fRxCUI 312837, 312839UNII 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
N429300026921followed by a unit qualifier and the quantityPackage 29300-0269-21. 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 orally disintegrating 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 orally disintegrating tablets should only be used where a clear diagn…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207835
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 10 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 71205-398 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | Tablet, Orally disintegratingOral | Unichem Pharmaceuticals (USA), Inc. | 29300-268 |