Prescription drug · ANDA
Sumatriptan NDC 69097-644
Sumatriptan 20 mg/1 · Spray · Nasal · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-644-48 | 69097064448 | 6 CONTAINER in 1 BOX (69097-644-48) / 1 SPRAY in 1 CONTAINERMarketed from Feb 22, 2021 |
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 — 20 mg/1
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214209
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69097-644_7426a8de-8412-4aee-a320-f30097e37f07SPL ID 7426a8de-8412-4aee-a320-f30097e37f07SPL set ID 559cca31-c0d2-45bf-999d-e92fc49a4a89RxCUI 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
N469097064448followed by a unit qualifier and the quantityPackage 69097-0644-48. 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 nasal spray is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache. Sumatriptan nasal spray is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatmen…
Excerpt only. Read the full label for complete information.