Prescription drug · ANDA
Sumatriptan NDC 69452-346
Sumatriptan succinate 100 mg/1 · Tablet, Film coated · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-346-72 | 69452034672 | 1 BLISTER PACK in 1 CARTON (69452-346-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-346-60)Marketed from Feb 18, 2022 |
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)
- Sumatriptan
- Generic name (nonproprietary)
- sumatriptan
- Active ingredients
- Sumatriptan succinate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bionpharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078284
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69452-346_4f61a0dc-b9b8-44a3-8fbf-f995a0c3931dSPL ID 4f61a0dc-b9b8-44a3-8fbf-f995a0c3931dSPL set ID e90b0eea-c424-4f00-98da-6ed6e80de1f6RxCUI 313160, 313161, 315223UNII J8BDZ68989
- 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
N469452034672followed by a unit qualifier and the quantityPackage 69452-0346-72. 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)
Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks. Sumatriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. Limitations…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078284
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 |
|---|---|---|---|---|
| Sumatriptan Succinate | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-596 |
| Sumatriptan | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-344 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-345 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-404 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0475 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-169 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8535 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0258 |
| Sumatriptan | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7436 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8619 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3525 |