SPRIX
These highlights do not include all the information needed to use SPRIX safely and effectively. See full prescribing information for SPRIX.SPRIX (ketorolac tromethamine) Nasal SprayInitial U.S. Approval: 1989
Approved
Approval ID
cc9e8fbc-ba36-444c-a61b-38dc4fd856b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ketorolac tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6284
Application NumberNDA022382
Product Classification
M
Marketing Category
C73594
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationNASAL
Effective DateJuly 25, 2011
FDA Product Classification
INGREDIENTS (5)
ketorolac tromethamineActive
Quantity: 15.75 mg in 1 1
Code: 4EVE5946BQ
Classification: ACTIB
potassium phosphate, monobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT