Prescription drug · ANDA
Sumatriptan (sumatriptan succinate) NDC 68071-4815
Sumatriptan succinate 50 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4815-9 | 68071481509 | 9 TABLET in 1 BLISTER PACK (68071-4815-9)Marketed from Mar 28, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 succinate
- Active ingredients
- Sumatriptan succinate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078327
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68071-4815_1add9269-c100-24d4-e063-6294a90add9aSPL ID 1add9269-c100-24d4-e063-6294a90add9aSPL set ID 85295be9-852d-4e21-e053-2991aa0a8a78RxCUI 313161UNII J8BDZ68989UPC 0368071481594
- 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
N468071481509followed by a unit qualifier and the quantityPackage 68071-4815-09. 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 tablets, 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 tablets are a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078327
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 |
|---|---|---|---|---|
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-6778 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-6769 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5072 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | NorthStar Rx LLC | 16714-798 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0224 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3350 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-2144 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1184 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Sportpharm LLC | 85766-093 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Sportpharm LLC | 85766-094 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Proficient Rx LP | 63187-797 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Sportpharm LLC | 85766-095 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-1129 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-1130 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0318 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NorthStar Rx LLC | 16714-797 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | NorthStar Rx LLC | 16714-796 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-498 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-499 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-500 |
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