Ketorolac Tromethamine
These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution 0.5% Initial U.S. Approval: 1991
Approved
Approval ID
92546f61-bbd8-430a-ac92-89dfbe8e2f29
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8549
Application NumberANDA203410
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
OCTOXYNOL-40Inactive
Code: 9T1C662FKS
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 5 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB