Sprix spray, metered

Ingredients and appearance - Product information

Sprix spray, metered- Ketorolac tromethamine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 45865-682
Route of Administration Nasal

Active Ingredient/Active Moiety

Ingredient Name Strength
Ketorolac tromethamine ( UNII: 4EVE5946BQ)( Ketorolac - UNII: YZI5105V0L ) 15.75 mgin 1

Inactive Ingredients

Ingredient Name Code
Edetate disodium ( UNII: 7FLD91C86K)
Potassium phosphate, monobasic ( UNII: 4J9FJ0HL51)
Sodium hydroxide ( UNII: 55X04QC32I)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA022382 USA

Labeler - Medsource Pharmaceuticals( 833685915)

Establishment

Name ID/FEI Business Operations
Medsource Pharmaceuticals 833685915 relabel( 45865-682)