Prescription drug · ANDA
Rizatriptan Benzoate NDC 65862-626
Rizatriptan benzoate 10 mg/1 · Tablet, Orally disintegrating · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-626-12 | 6586206261265862062612 | 4 BLISTER PACK in 1 CARTON (65862-626-12) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-03)Marketed from Jul 1, 2013 | |
| 65862-626-18 | 6586206261865862062618 | 3 BLISTER PACK in 1 CARTON (65862-626-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-06)Marketed from Jul 1, 2013 | |
| 65862-626-36 | 6586206263665862062636 | 9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-626-36)Marketed from Mar 5, 2018 | |
| 65862-626-48 | 6586206264865862062648 | 18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-626-48)Marketed from Mar 5, 2018 | |
| 65862-626-64 | 6586206266465862062664 | 1 BLISTER PACK in 1 CARTON (65862-626-64) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-03)Marketed from Aug 28, 2023 | |
| 65862-626-90 | 6586206269065862062690 | 3 BLISTER PACK in 1 CARTON (65862-626-90) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-03)Marketed from Jul 1, 2013 |
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
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203062
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 65862-626_b813e372-4315-4a35-a6dd-592b69aee7b8SPL ID b813e372-4315-4a35-a6dd-592b69aee7b8SPL set ID a8e37688-426c-4290-933d-54a34ae86000RxCUI 312837, 312839UNII WR978S7QHHUPC 0365862625366
- 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
N465862062612followed by a unit qualifier and the quantityPackage 65862-0626-12. 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, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management…
Excerpt only. Read the full label for complete information.
About NDC 65862-626
- What is NDC 65862-626?
- 65862-626 is the product NDC for Rizatriptan Benzoate, Rizatriptan benzoate 10 mg/1 tablet, orally disintegrating, listed with the FDA by Aurobindo Pharma Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rizatriptan Benzoate.
- What is the active ingredient?
- Rizatriptan benzoate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rizatriptan Benzoate?
- 56 other product NDCs are listed under this name. See all Rizatriptan Benzoate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rizatriptan Benzoate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0535 | 80425-0535-01 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | REMEDYREPACK INC. | 70518-4362 | 70518-4362-00 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | TabletOral | Direct_Rx | 72189-512 | 72189-0512-18 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-447 | 72189-0447-18 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | TabletOral | Direct Rx | 72189-316 | 72189-0316-18 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | TabletOral | direct rx | 72189-258 | 72189-0258-1272189-0258-18 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | TabletOral | DIRECT RX | 61919-656 | 61919-0656-12 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | TabletOral | DIRECT RX | 61919-394 | 61919-0394-18 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | Tablet, Orally disintegratingOral | Unichem Pharmaceuticals (USA), Inc. | 29300-268 | 29300-0268-2129300-0268-8129300-0268-91 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Unichem Pharmaceuticals (USA), Inc. | 29300-269 | 29300-0269-2129300-0269-8129300-0269-91 |
Other NDCs under ANDA 203062
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 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-085 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-086 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | REMEDYREPACK INC. | 70518-4362 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2982 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-625 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-3568 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | Tablet, Orally disintegratingOral | Asclemed USA, Inc. | 76420-908 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Asclemed USA, Inc. | 76420-909 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 71205-557 |
| Rizatriptan Benzoate ODT | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Direct Rx | 72189-341 |
| Rizatriptan Benzoate | Rizatriptan benzoate 5 mg/1 | Tablet, Orally disintegratingOral | Golden State Medical Supply, Inc. | 51407-679 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Golden State Medical Supply, Inc. | 51407-680 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-1819 |
| Rizatriptan Benzoate | Rizatriptan benzoate 10 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0535 |