Prescription drug · ANDA
Sumatriptan Succinate NDC 76420-093
Sumatriptan succinate 50 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-093-09 | 76420009309 | 9 BLISTER PACK in 1 CARTON (76420-093-09) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 24, 2020 |
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 Succinate
- Generic name (nonproprietary)
- sumatriptan succinate
- Active ingredients
- Sumatriptan succinate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076847
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76420-093_b26ec84b-1af1-b04d-e053-2a95a90a8c78SPL ID b26ec84b-1af1-b04d-e053-2a95a90a8c78SPL set ID b16886d0-224b-4d83-85c4-bc3eb3606c17RxCUI 313161UNII 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
N476420009309followed by a unit qualifier and the quantityPackage 76420-0093-09. 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 tablets are administered to treat any subsequent attacks. • Sumatriptan tablets are 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-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076847
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 | TabletOral | Proficient Rx LP | 63187-617 |
| Sumatriptan Succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Proficient Rx LP | 63187-607 |
| Sumatriptan Succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4562 |
| Sumatriptan Succinate | Sumatriptan succinate 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2283 |
| Sumatriptan Succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-291 |
| Sumatriptan Succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-292 |
| Sumatriptan Succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-293 |
| Sumatriptan Succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Proficient Rx LP | 63187-049 |