Prescription drug · ANDA
Sumatriptan (Sumatriptan succinate) NDC 68788-9547
Sumatriptan succinate 50 mg/1 · Tablet · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-9547-9 | 68788954709 | 1 BLISTER PACK in 1 CARTON (68788-9547-9) / 9 TABLET in 1 BLISTER PACKMarketed from Oct 24, 2013 |
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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- 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 68788-9547_9809757f-b006-4441-92ec-63b3f1319e94SPL ID 9809757f-b006-4441-92ec-63b3f1319e94SPL set ID f2e7d756-1e12-462a-a43f-a9d860b11ee8RxCUI 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
N468788954709followed by a unit qualifier and the quantityPackage 68788-9547-09. 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 …
Excerpt only. Read the full label for complete information.
About NDC 68788-9547
- What is NDC 68788-9547?
- 68788-9547 is the product NDC for Sumatriptan (sumatriptan succinate), Sumatriptan succinate 50 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sumatriptan (Sumatriptan Succinate).
- What is the active ingredient?
- Sumatriptan succinate.
- Who is the labeler?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sumatriptan?
- 72 other product NDCs are listed under this name. See all Sumatriptan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sumatriptan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Armas Pharmaceuticals Inc. | 72485-518 | 72485-0518-05 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | Strides Pharma Science Limited | 64380-740 | 64380-0740-0164380-0740-02 |
| sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-151 | 83270-0151-07 |
| sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-152 | 83270-0152-07 |
| sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-005 | 83270-0005-01 |
| sumatriptan | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-660 | 64980-0660-2764980-0660-3664980-0660-91 |
| sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-661 | 64980-0661-2764980-0661-3664980-0661-91 |
| sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-662 | 64980-0662-2764980-0662-3664980-0662-91 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0475 | 80425-0475-01 |
| Sumatriptan | Sumatriptan succinate 6 mg/.5mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-7957 | 50090-7957-00 |
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 25 mg/1 | TabletOral | NorthStar Rx LLC | 16714-796 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NorthStar Rx LLC | 16714-797 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | NorthStar Rx LLC | 16714-798 |
| 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 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-2144 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Quality Care Products, LLC | 55700-899 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Proficient Rx LP | 63187-797 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Proficient Rx LP | 63187-931 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Proficient Rx LP | 63187-969 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-146 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3350 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3755 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3802 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4815 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5072 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-6769 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-6778 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1184 |
| Sumatriptansumatriptan succinate | Sumatriptan succinate 50 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-498 |
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