SPL Set ID: 7328ab4f-2985-448d-8724-8f1b55693b41

1 drug(s) with this SPL Set ID

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SUMATRIPTAN SUMATRIPTAN
5 mg Spray
BRYANT RANCH PREPACK FDA Rx Only

Sumatriptan Nasal Spray, USP contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure: The empirical formula is C 14 H 21 N 3 O 2 S, representing a molecular weight of 295.4. Sumatriptan is a white to pale yellow powder that is very slightly soluble in water. Each Sumatriptan Nasal Spray contains 5 or 20 mg of sumatriptan in a 100-microL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, benzalkonium chloride solution NF, edetate disodium dihydrate USP and purified water USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg Sumatriptan Nasal Spray, respectively.

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