Prescription drug · ANDA
Sumatriptan NDC 45802-619
Sumatriptan 5 mg/1 · Spray · Nasal · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-619-06 | 4580206190645802061906 | 6 CONTAINER in 1 CARTON (45802-619-06) / 1 SPRAY in 1 CONTAINER (45802-619-00)Marketed from Oct 4, 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
- Generic name (nonproprietary)
- sumatriptan
- Active ingredients
- Sumatriptan — 5 mg/1
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213465
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 45802-619_d1aeb8e8-e726-405a-bf9d-7436af66c48bSPL ID d1aeb8e8-e726-405a-bf9d-7436af66c48bSPL set ID 6d521807-e5ce-498d-a224-5534c5ea61faRxCUI 313159, 314227UNII 8R78F6L9VO
- 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N445802061906followed by a unit qualifier and the quantityPackage 45802-0619-06. 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 Nasal Spray is 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 Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks. • Sumatriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of Sumatriptan Nasal Spray 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…
Excerpt only. Read the full label for complete information.
About NDC 45802-619
- What is NDC 45802-619?
- 45802-619 is the product NDC for Sumatriptan, Sumatriptan 5 mg/1 spray, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. 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.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 213465
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 20 mg/1 | SprayNasal | Padagis Israel Pharmaceuticals Ltd | 45802-598 |
| Sumatriptan | Sumatriptan 20 mg/1 | SprayNasal | Bryant Ranch Prepack | 63629-8703 |