SPL Set ID: 3bda47b0-0326-49de-83f5-03b9ec6461f1

1 drug(s) with this SPL Set ID

Open DailyMed details

Ipratropium Bromide IPRATROPIUM BROMIDE
AMNEAL PHARMACEUTICALS NY LLC FDA Rx Only

The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate ( endo,syn )-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: C 20 H 30 BrNO 3 •H 2 O ipratropium bromide, USP Mol. Wt. 430.4 Ipratropium bromide, USP is a white or almost white crystalline substance, freely soluble in methanol, soluble in water, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 μL) in an isotonic, aqueous solution with pH-adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 165 sprays. Structural Formula

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