Prescription drug · ANDA
Sumatriptan NDC 82804-169
Sumatriptan succinate 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-169-09 | 8280401690982804016909 | 1 BLISTER PACK in 1 CARTON (82804-169-09) / 9 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 23, 2024 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-169_85bf8e58-0984-427b-9ed4-7e0df4e444d2SPL ID 85bf8e58-0984-427b-9ed4-7e0df4e444d2SPL set ID 85bf8e58-0984-427b-9ed4-7e0df4e444d2RxCUI 313161UNII J8BDZ68989UPC 0382804169092
- 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
N482804016909followed by a unit qualifier and the quantityPackage 82804-0169-09. 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 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. Limit…
Excerpt only. Read the full label for complete information.
About NDC 82804-169
- What is NDC 82804-169?
- 82804-169 is the product NDC for Sumatriptan, Sumatriptan succinate 50 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sumatriptan.
- What is the active ingredient?
- Sumatriptan succinate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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?
- 75 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 | A-S Medication Solutions | 50090-8109 | 50090-8109-00 |
| 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 |
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 | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7436 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3525 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8535 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8619 |
| 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 | Bionpharma Inc. | 69452-346 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-404 |
| Sumatriptan | Sumatriptan succinate 100 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0258 |
| Sumatriptan | Sumatriptan succinate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0475 |
| Sumatriptan Succinate | Sumatriptan succinate 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-596 |