Prescription drug · ANDA
Rizatriptan Benzoate NDC 43817-133
Rizatriptan benzoate 5 mg/1 · Tablet, Orally disintegrating · Oral · Panacea Biotec Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43817-133-04 | 43817013304 | 6 BLISTER PACK in 1 CARTON (43817-133-04) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (43817-133-03)Marketed from Jan 17, 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
- Labeler
- Panacea Biotec Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204722
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43817-133_28d0cbcc-59cc-7cf4-e063-6294a90a9b53SPL ID 28d0cbcc-59cc-7cf4-e063-6294a90a9b53SPL set ID 9c70370d-72ac-e062-e25c-97d57e6397abRxCUI 312837, 312839UNII WR978S7QHHUPC 0343817135047, 0343817135030, 0343817133036
- 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
N443817013304followed by a unit qualifier and the quantityPackage 43817-0133-04. 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 .
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, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204722
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 | Panacea Biotec Limited | 43817-135 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc., | 69452-156 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Bionpharma Inc., | 69452-157 |