Prescription drug · ANDA
Rizatriptan NDC 33342-088
Rizatriptan benzoate 10 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-088-07 | 33342008807 | 30 TABLET, FILM COATED in 1 CONTAINER (33342-088-07)Marketed from Mar 11, 2014 | |
| 33342-088-12 | 33342008812 | 10 BLISTER PACK in 1 CARTON (33342-088-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 11, 2014 | |
| 33342-088-41 | 33342008841 | 3 BLISTER PACK in 1 CARTON (33342-088-41) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-02)Marketed from Sep 3, 2018 | |
| 33342-088-45 | 33342008845 | 2 BLISTER PACK in 1 CARTON (33342-088-45) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-02)Marketed from Sep 3, 2018 | |
| 33342-088-46 | 33342008846 | 200 TABLET, FILM COATED in 1 CONTAINER (33342-088-46)Marketed from Mar 11, 2014 | |
| 33342-088-50 | 33342008850 | 4 BLISTER PACK in 1 CARTON (33342-088-50) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-52)Marketed from Mar 11, 2014 | |
| 33342-088-72 | 33342008872 | 6 BLISTER PACK in 1 CARTON (33342-088-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-52)Marketed from Mar 11, 2014 |
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
- Generic name (nonproprietary)
- rizatriptan
- Active ingredients
- Rizatriptan benzoate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203147
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 33342-088_fe80232a-c329-47ed-8edd-7786e06f3c08SPL ID fe80232a-c329-47ed-8edd-7786e06f3c08SPL set ID 27bc2cfc-fefb-4b50-a0dc-6268c69b4902RxCUI 312840, 314209UNII WR978S7QHHUPC 0333342088468, 0333342087072, 0333342088079, 0333342087461
- 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
N433342008807followed by a unit qualifier and the quantityPackage 33342-0088-07. 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)
Ri zatriptan 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 patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ]. • Rizatriptan benzoate tablets are not i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203147
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, Film coatedOral | Direct_Rx | 72189-447 |
| Rizatriptan | Rizatriptan benzoate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7747 |
| Rizatriptan | Rizatriptan benzoate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2980 |
| Rizatriptan | Rizatriptan benzoate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1352 |
| Rizatriptan | Rizatriptan benzoate 5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-087 |