sumatriptan
sumatriptan is listed in the FDA National Drug Code directory with 31 NDC codes, marketed under brand names including SUMATRIPTAN, sumatriptan, IMITREX. Available dosage forms: injection, solution, spray, injection, tablet, film coated.
Drug Details
- Generic Name
- sumatriptan
- Brand Names
- SUMATRIPTAN, sumatriptan, IMITREX, Sumatriptan, TOSYMRA
- Application Number
- ANDA090314
- Sponsor
- Golden State Medical Supply, Inc.
- NDC Codes
- 31
- Dosage Forms
- INJECTION, SOLUTION, SPRAY, INJECTION, TABLET, FILM COATED
- Routes
- SUBCUTANEOUS, NASAL, ORAL
- Active Ingredients
- SUMATRIPTAN SUCCINATE, SUMATRIPTAN
Indications and Usage
1 INDICATIONS AND USAGE Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Sumatriptan injection, USP is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults ( 1 ) Acute treatment of cluster headache in adults ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established ( 1 ) Not indicated for the prophylactic therapy of migraine or cluster headache attacks ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Sumatriptan Injection, reconsider the diagnosis before Sumatriptan Injection is administered to treat any subsequent attacks. Sumatriptan Injection is not indicated for the prevention of migraine attacks or cluster headache attacks.