Prescription drug · NDA
Tosymra (Sumatriptan) NDC 0245-0812
Sumatriptan 10 mg/.1mL · Spray · Nasal · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-0812-61 | 00245081261 | 6 BLISTER PACK in 1 CARTON (0245-0812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK (0245-0812-89) / .1 mL in 1 BOTTLE, SPRAY (0245-0812-59)Marketed from Sep 1, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tosymra
- Generic name (nonproprietary)
- sumatriptan
- Active ingredients
- Sumatriptan — 10 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0245
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210884
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0245-0812_27349402-73d3-3a2e-e063-6394a90a7099SPL ID 27349402-73d3-3a2e-e063-6394a90a7099SPL set ID 015a5cf9-f246-48bc-b91e-cd730a53d8aaRxCUI 401978, 2178073UNII 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
N400245081261followed by a unit qualifier and the quantityPackage 00245-0812-61. 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)
TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established ( 1 ) Not indicated for the preventive treatment of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks. T…
Excerpt only. Read the full label for complete information.
About NDC 0245-0812
- What is NDC 0245-0812?
- 0245-0812 is the product NDC for Tosymra (sumatriptan), Sumatriptan 10 mg/.1mL spray, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tosymra (Sumatriptan).
- What is the active ingredient?
- Sumatriptan.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tosymra?
- 1 other product NDC are listed under this name. See all Tosymra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tosymra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tosymrasumatriptan | Sumatriptan 10 mg/.1mL | SprayNasal | Tonix Medicines, Inc. | 70792-812 | 70792-0812-5970792-0812-6170792-0812-89 |
Other NDCs under NDA 210884
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 |
|---|---|---|---|---|
| Tosymrasumatriptan | Sumatriptan 10 mg/.1mL | SprayNasal | Tonix Medicines, Inc. | 70792-812 |