Prescription drug · ANDA
Rizatriptan Benzoate NDC 82619-112
Rizatriptan benzoate 10 mg/1 · Tablet · Oral · Creekwood Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82619-112-01 | 8261901120182619011201 | 30 TABLET in 1 BOTTLE (82619-112-01)Marketed from Sep 15, 2023 | |
| 82619-112-02 | 8261901120282619011202 | 1000 TABLET in 1 BOTTLE (82619-112-02)Marketed from Sep 15, 2023 | |
| 82619-112-04 | 8261901120482619011204 | 2 BLISTER PACK in 1 CARTON (82619-112-04) / 6 TABLET in 1 BLISTER PACKMarketed from Sep 15, 2023 | |
| 82619-112-05 | 8261901120582619011205 | 3 BLISTER PACK in 1 CARTON (82619-112-05) / 6 TABLET in 1 BLISTER PACKMarketed from Sep 15, 2023 |
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
- Labeler
- Creekwood Pharmaceuticals LLCNDC labeler code 82619
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202047
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 82619-112_40b947bf-a78e-6681-e063-6294a90ad145SPL ID 40b947bf-a78e-6681-e063-6294a90ad145SPL set ID b517896b-167e-47d5-801d-7458f80e8ee2RxCUI 312840, 314209UNII WR978S7QHH
- 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
N482619011201followed by a unit qualifier and the quantityPackage 82619-0112-01. 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 indicat…
Excerpt only. Read the full label for complete information.
About NDC 82619-112
- What is NDC 82619-112?
- 82619-112 is the product NDC for Rizatriptan Benzoate, Rizatriptan benzoate 10 mg/1 tablet, listed with the FDA by Creekwood Pharmaceuticals LLC. It has 4 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?
- Creekwood Pharmaceuticals LLC, NDC labeler code 82619. 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 202047
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 | Creekwood Pharmaceuticals LLC | 82619-111 |