Prescription drug · ANDA
rizatriptan benzoate NDC 68462-466
Rizatriptan benzoate 10 mg/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-466-72 | 68462046672 | 12 POUCH in 1 CARTON (68462-466-72) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACKMarketed from Dec 31, 2012 | |
| 68462-466-99 | 68462046699 | 18 POUCH in 1 CARTON (68462-466-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACKMarketed from Dec 31, 2012 |
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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201967
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-466_c7909d7b-34a6-42b0-ad12-eb25f3ce886eSPL ID c7909d7b-34a6-42b0-ad12-eb25f3ce886eSPL set ID 99c66300-bd75-4b31-9fab-88c6e4b12688RxCUI 312840, 314209UNII WR978S7QHHUPC 0368462465998, 0368462466995
- 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
N468462046672followed by a unit qualifier and the quantityPackage 68462-0466-72. 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 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 201967
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 | Glenmark Pharmaceuticals Inc., USA | 68462-465 |
- openFDA data updated
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