Prescription drug · ANDA
Rizatriptan Benzoate NDC 29300-316
Rizatriptan benzoate 5 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-316-21 | 2930003162129300031621 | 4 BLISTER PACK in 1 CARTON (29300-316-21) / 3 TABLET in 1 BLISTER PACK (29300-316-31)Marketed from Jul 5, 2017 | |
| 29300-316-81 | 2930003168129300031681 | 6 BLISTER PACK in 1 CARTON (29300-316-81) / 3 TABLET in 1 BLISTER PACK (29300-316-31)Marketed from Jul 5, 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
- Route
- Oral
- Labeler
- Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207836
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 29300-316_b86514bb-961e-4cf9-9f52-d5f441b7c97fSPL ID b86514bb-961e-4cf9-9f52-d5f441b7c97fSPL set ID 35f26d3c-268b-4114-9b5b-1c2e0b9ddfd5RxCUI 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
N429300031621followed by a unit qualifier and the quantityPackage 29300-0316-21. 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 is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use: Use only after clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 ) 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…
Excerpt only. Read the full label for complete information.
About NDC 29300-316
- What is NDC 29300-316?
- 29300-316 is the product NDC for Rizatriptan Benzoate, Rizatriptan benzoate 5 mg/1 tablet, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 2 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?
- Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 207836
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 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-317 |