Prescription drug · ANDA
rizatriptan benzoate NDC 33342-093
Rizatriptan benzoate 5 mg/1 · Tablet, Orally disintegrating · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-093-04 | 33342009304 | 12 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-04)Marketed from Feb 27, 2023 | |
| 33342-093-07 | 33342009307 | 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-07)Marketed from Sep 23, 2014 | |
| 33342-093-12 | 33342009312 | 10 BLISTER PACK in 1 CARTON (33342-093-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 23, 2014 | |
| 33342-093-23 | 33342009323 | 18 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-23)Marketed from Feb 27, 2023 | |
| 33342-093-41 | 33342009341 | 3 BLISTER PACK in 1 CARTON (33342-093-41) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 4, 2018 | |
| 33342-093-45 | 33342009345 | 2 BLISTER PACK in 1 CARTON (33342-093-45) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 19, 2018 | |
| 33342-093-46 | 33342009346 | 200 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-46)Marketed from Sep 23, 2014 | |
| 33342-093-48 | 33342009348 | 4 POUCH in 1 CARTON (33342-093-48) / 1 BLISTER PACK in 1 POUCH / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Sep 23, 2014 | |
| 33342-093-52 | 33342009352 | 1 BLISTER PACK in 1 CARTON (33342-093-52) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 13, 2017 | |
| 33342-093-72 | 33342009372 | 6 BLISTER PACK in 1 CARTON (33342-093-72) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 13, 2017 | |
| 33342-093-73 | 33342009373 | 3 BLISTER PACK in 1 CARTON (33342-093-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 13, 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 — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203146
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 33342-093_137f6265-8c70-4748-a0d5-3976274e4ea0SPL ID 137f6265-8c70-4748-a0d5-3976274e4ea0SPL set ID 57ed2505-28f1-4292-b3c3-a49bf0f7c683RxCUI 312837, 312839UNII WR978S7QHHUPC 0333342094452, 0333342094414, 0333342094469, 0333342094520, 0333342093455, 0333342093417
- 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
N433342009304followed by a unit qualifier and the quantityPackage 33342-0093-04. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
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 diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203146
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 | Macleods Pharmaceuticals Limited | 33342-094 |
| Rizatriptan Benzoate ODT | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Direct_rx | 72189-609 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.