KETOROLAC TROMETHAMINE
These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% KETOROLAC TROMETHAMINE ophthalmic solution Initial U.S. Approval: 1991
Approved
Approval ID
ae2e626c-0019-7c4e-e053-2995a90a23be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2252
Application NumberANDA076583
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 5 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT